Less-invasive devices and methods for treatment of cardiac valves

ABSTRACT

Devices and methods are provided for less-invasive surgical treatment of cardiac valves whereby the need for a gross thoracotomy or median sternotomy is eliminated. In one aspect of the invention, a delivery system for a cardiac valve prosthesis such as an annuloplasty ring or prosthetic valve includes an elongated handle configured to extend into the heart through an intercostal space from outside of the chest cavity, and a prosthesis holder attached to the handle for releasably holding a prosthesis. The prosthesis holder is attached to the handle in such a way that the holder, prosthesis and handle have a profile with a height smaller than the width of an intercostal space when the adjacent ribs are unretracted, preferably less than about 30 mm. In a further aspect, the invention provides a method for repairing or replacing a heart valve which includes the steps of introducing a prosthesis through an intercostal space and through a penetration in a wall of the heart, and securing the prosthesis to an interior wall of the heart, wherein each step is carried out without cutting, removing, or significantly retracting the ribs or sternum.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of co-pending application Ser.No. 08/949,282, filed Oct. 21, 1997, which is a file wrappercontinuation of application Ser. No. 08/485,600, filed Jun. 7, 1995, nowabandoned, which is a continuation-in-part of application Ser. No.08/281,962, filed Jul. 28, 1994, now abandoned, which is acontinuation-in-part of application Ser. No. 08/163,241, filed Dec. 6,1993, now issued as U.S. Pat. No. 5,571,215, which is acontinuation-in-part of application Ser. No. 08/023,778, filed Feb. 22,1993, now issued as U.S. Pat. No. 5,452,733, the complete disclosures ofwhich are hereby incorporated herein by reference for all purposes.

FIELD OF THE INVENTION

[0002] The present invention relates generally to devices and methodsfor performing surgery on the heart. More specifically, the inventionrelates to less-invasive devices and methods for the surgical treatmentof diseased heart valves.

BACKGROUND OF THE INVENTION

[0003] Heart valve disease is a widespread condition in which one ormore of the valves of the heart fails to function properly. Diseasedheart valves may be categorized as either stenotic, wherein the valvedoes not open sufficiently to allow adequate forward flow of bloodthrough the valve, or incompetent, wherein the valve does not closecompletely, causing excessive backward flow of blood through the valvewhen the valve is closed. A heart valve may also be both stenotic andincompetent. Valve disease can be severely debilitating and even fatalif left untreated, particularly if the diseased valve is the mitralvalve (between the left atrium and left ventricle) or the aortic valve(between the left ventricle and the aorta). According to recentestimates, more than 80,000 patients are diagnosed with aortic or mitralvalve disease in U.S. hospitals each year.

[0004] Various surgical techniques may be used to repair a diseased ordamaged valve. One repair technique which has been shown to be effectivein treating incompetence, particularly of the mitral and tricuspidvalves, is annuloplasty, in which the effective size of the valveannulus is contracted by attaching a prosthetic annuloplasty ring to aninterior wall of the heart around the valve annulus. The annuloplastyring comprises an inner substrate of a metal such as stainless ortitanium, or a flexible material such as silicone rubber or Dacroncordage, covered with a biocompatible fabric or cloth to allow the ringto be sutured to the heart tissue. The annuloplasty ring may be stiff orflexible, may be split or continuous, and may have a variety of shapes,including circular, D-shaped, C-shaped, or kidney-shaped. Examples areseen in U.S. Pat. Nos.4,917,698, 5,061,277, 5,290,300, 5,350,420,5,104,407, 5,064,431, 5,201,880, and 5,041,130, which are incorporatedherein by reference.

[0005] Annuloplasty rings may also be utilized in combination with otherrepair techniques such as quadrangular resection, in which a portion ofa valve leaflet is excised, the remaining portions of the leaflet aresewn back together, and a prosthetic annuloplasty ring is then attachedto the valve annulus to maintain the contracted size of the valve. Othervalve repair techniques in current use include commissurotomy (cuttingthe valve commissures to separate the valve leaflets), shortening mitralor tricuspid valve chordae tendonae, reattachment of severed mitral ortricuspid valve chordae tendonae or papillary muscle tissue, anddecalcification of the valve leaflets or annulus. Annuloplasty rings maybe used in conjunction with any repair procedures where contracting orstabilizing the valve annulus might be desirable.

[0006] In cases where a cardiac valve is not suited to repair, the valvemay be replaced, by excising the valve leaflets of the natural valve,and securing a replacement valve in the valve position, usually bysuturing the replacement valve to the natural valve annulus. Varioustypes of replacement valves are in current use, including mechanical andbiological prostheses, homografts, and allografts, as described inBodnar and Frater, Replacement Cardiac Valves 1-357 (1991). Acomprehensive discussion of heart valve diseases and the surgicaltreatment thereof is found in Kirklin and Barratt-Boyes. Cardiac Surgery323-459 (1986).

[0007] Using current techniques, most valve repair and replacementprocedures require a gross thoracotomy, usually in the form of a mediansternotomy, to gain access into the patient's thoracic cavity. A saw orother cutting instrument is used to cut the sternum longitudinally,allowing two opposing halves of the anterior or ventral portion of therib cage to be spread apart. A large opening into the thoracic cavity isthus created, through which the surgical team may directly visualize andoperate upon the heart and other thoracic contents. Alternatively, athoracotomy may be performed on a lateral side of the chest, wherein alarge incision is made generally parallel to the ribs, and the ribs arespread apart and/or removed in the region of the incision to create alarge enough opening to facilitate the surgery.

[0008] Surgical intervention within the heart generally requiresisolation of the heart and coronary blood vessels from the remainder ofthe arterial system, and arrest of cardiac function. Usually, the heartis isolated from the arterial system by introducing an external aorticcross-clamp through a sternotomy and applying it to the aorta to occludethe aortic lumen between the brachiocephalic artery and the coronaryostia. Cardioplegic fluid is then injected into the coronary arteries,either directly into the coronary ostia or through a puncture in theascending aorta, so as to arrest cardiac function. In some cases,cardioplegic fluid is injected into the coronary sinus for retrogradeperfusion of the myocardium. The patient is placed on extracorporealcardiopulmonary bypass to maintain peripheral circulation of oxygenatedblood.

[0009] Of particular interest in the present application are techniquesfor the repair and replacement of the mitral valve. The mitral valve,located between the left atrium and left ventricle of the heart, is mosteasily reached through the wall of the left atrium, which normallyresides on the posterior side of the heart, opposite the side of theheart that is exposed by a median sternotomy. Therefore, to access themitral valve via a sternotomy, the heart is rotated to bring the leftatrium into an anterior position accessible through the sternotomy. Anopening, or atriotomy, is then made in the right side of the leftatrium, anterior to the right pulmonary veins. The atriotomy isretracted by means of sutures or a retraction device, exposing themitral valve directly posterior to the atriotomy. One of theforementioned techniques may then be used to repair or replace thevalve.

[0010] An alternative technique for mitral valve access may be used whena median sternotomy and/or rotational manipulation of the heart areinappropriate. In this technique, a thoracotomy is made in the rightlateral side of the chest, usually in the region of the fourth or fifthintercostal space. One or more ribs may be removed from the patient, andother ribs near the incision are retracted outward to create a largeopening into the thoracic cavity. The left atrium is then exposed on theposterior side of the heart, and an atriotomy is formed in the wall ofthe left atrium, through which the mitral valve may be accessed forrepair or replacement.

[0011] Using such open-chest techniques, the large opening provided by amedian sternotomy or right thoracotomy enables the surgeon to see themitral valve directly through the left atriotomy, and to position his orher hands within the thoracic cavity in close proximity to the exteriorof the heart for cannulation of the aorta and/or coronary arteries toinduce cardioplegia, manipulation of surgical instruments, removal ofexcised tissue, and introduction of an annuloplasty ring or areplacement valve through the atriotomy for attachment within the heart.However, these invasive, open-chest procedures produce a high degree oftrauma, a significant risk of complications, an extended hospital stay,and a painful recovery period for the patient. Moreover, while heartvalve surgery produces beneficial results for many patients, numerousothers who might benefit from such surgery are unable or unwilling toundergo the trauma and risks of current techniques.

[0012] What is needed, therefore, are devices and methods for carryingout heart valve repair and replacement as well as other procedureswithin the heart and great vessels that reduce the trauma, risks,recovery time and pain that accompany current techniques. The devicesand methods should facilitate surgical intervention within the heart orgreat vessels without the need for a gross thoracotomy, preferablythrough small incisions within intercostal spaces of the rib cage,without cutting, removing, or significantly deflecting the patient'sribs or sternum. In particular, the devices and methods should allow forremoval of tissue from the thoracic cavity, as well as for introductionof surgical instruments, visualization devices, annuloplasty rings,replacement valves, and the like into the thoracic cavity, to facilitateheart valve repair and replacement. The devices and methods shouldenable the implantation of annuloplasty rings of various shape, size,and stiffness. In addition, the devices and methods should facilitatereplacement of a heart valve with various types of prostheses, includingmechanical and biological prostheses, homografts, and allografts.

SUMMARY OF THE INVENTION

[0013] The invention provides devices and methods for performingless-invasive surgical procedures within an organ or vessel, andparticularly, within the heart and great vessels of the thoracic cavity.The devices and methods of the invention facilitate intervention withinthe heart and great vessels without the need for a median sternotomy orother form of gross thoracotomy, substantially reducing trauma, risk ofcomplication, recovery time, and pain for the patient. Using the devicesand methods of the invention, surgical procedures may be performedthrough percutaneous penetrations within intercostal spaces of thepatient's rib cage, without cutting, removing, or significantlydisplacing any of the patient's ribs or sternum. The devices and methodsare particularly well-adapted for heart valve repair and replacement,facilitating visualization within the patient's thoracic cavity, repairor removal of the patient's natural valve, and, if necessary, attachmentof an annuloplasty ring or a replacement valve in the natural valveposition. The invention facilitates valve repair with a variety ofdifferent annuloplasty rings, as well as valve replacement with any of avariety of replacement valves, including mechanical prostheses,bioprostheses, homografts, and allografts.

[0014] According to the invention, access into the chest cavity and intothe heart is obtained by means of small incisions, punctures, cannulae,trocars, or other percutaneous penetrations of minimal size positionedin the intercostal spaces between adjacent ribs of the rib cage. In thisapplication, these percutaneous penetrations within intercostal spaceswill be referred to as “intercostal ports.” The intercostal portsutilized in the present invention will not require removal, cutting, orother modification of the ribs or sternum, and will generally avoid anysignificant retraction of the ribs, other than the incidental deflectionof the ribs which may occur when a cannula, trocar, or other means oftissue retraction is placed in an intercostal space. Such retraction ofribs will generally be avoided entirely, and if occurring at all, willbe limited to deflection of less than about one centimeter. Preferably,all such intercostal ports will have a width (or diameter, if round) ofless than 30 mm in order to fit within an intercostal space withoutsignificant rib retraction, and in many cases will have a width of lessthan 12 mm so as to minimize trauma.

[0015] In a first aspect, the invention provides a method ofclosed-chest repair of a heart valve. Utilizing the method of theinvention, the patient's heart is arrested and cardiopulmonary bypass isestablished. The interior of the patient's chest cavity is viewed bymeans of a thoracoscope or by directly looking through a cannula orother retracting means positioned in an intercostal space. A knife orscissors is introduced through an intercostal port into the patient'schest, and the cutting means is used to first form an opening in thepericardium, then to form a cardiac penetration in a wall of the heart.One or more percutaneous cannulae, trocars, or other means of retractingtissue may be positioned in an incision or puncture within anintercostal space through which various instruments may be introducedinto the chest cavity. These instruments may be positioned through thecardiac penetration to perform, for example, annuloplasty, quadrangularresection of valve leaflets, commissurotomy, reattachment of chordaetendonae or papillary muscle tissue, shortening of chordae tendonae,decalcification, and the like. Advantageously, all of these steps may beperformed without cutting, removing, or substantially retracting theribs or sternum, eliminating the pain, trauma, long recovery time, andcomplications associated with gross thoracotomy.

[0016] The patient's heart is preferably arrested by occluding thepatient's aorta between the patient's coronary ostia and the patient'sbrachiocephalic artery with an expandable member on a distal end of anendovascular aortic catheter introduced through a peripheral artery suchas a femoral artery. Cardioplegic fluid is then delivered through alumen in the catheter into the patient's aorta upstream of theexpandable member to arrest cardiac function. Alternatively, or inaddition to such antegrade cardioplegic fluid delivery, cardioplegicfluid may be delivered in a retrograde manner by means of a catheterpositioned in the coronary sinus of the patient's heart. In analternative approach, an external cross-clamp may be placedthoracoscopically on the aorta through a small incision or cannula inthe patient's chest. Cardioplegic fluid may be delivered either througha cannula introduced thoracoscopically and inserted through the aorticwall, or through an endovascular aortic catheter extending from aperipheral artery into the ascending aorta upstream of the cross-clamp.

[0017] In a preferred embodiment of the method, a prostheticannuloplasty ring is introduced through an intercostal port and into aninternal chamber of the heart, and the ring is attached to the heartwall around the annulus of the valve within the internal chamber.Usually, the valve will first be sized by introducing a sizing devicethrough the intercostal port and into the heart through the cardiacpenetration, and positioning the sizing device adjacent to the valve tomeasure its size. A valve sizing disk attached to an elongated shaft orhandle may be used for this purpose. Once the valve size has beendetermined, sutures are inserted in the native valve annulus and anannuloplasty ring of appropriate size is selected. The ring is attachedto an elongated handle and the ring is introduced through an intercostalport and through the cardiac penetration into the heart. Theannuloplasty ring is then secured to the annulus of the heart valve, bytying knots in the sutures extracorporeally and pushing the knots intothe heart with an elongated knot-pusher. The sutures are preferablyapplied to the annuloplasty ring outside of the chest cavity, and thering is slid along the sutures through the intercostal port and cardiacpenetration up to the valve annulus. The sutures are then tied andtrimmed using thoracoscopic instruments.

[0018] One advantage of the method of the invention is that it allowsthe surgeon to obtain access to the valve through an intercostal portand a cardiac penetration, assess the nature and extent of valvedisease, and then decide whether to repair or replace the valve. If thedisease is such that repair is inappropriate, the surgeon may elect toreplace the valve with any of a variety of replacement valves. A valvereplacement method according to the invention may include the step ofremoving all or part of the patient's natural heart valve by means of acutting tool introduced through an intercostal port and through thecardiac penetration into the heart. The method further comprises thestep of introducing a replacement valve through an intercostal port andthrough the cardiac penetration into the internal chamber of the heart.The replacement valve is then fastened within the heart, usually bymeans of a suturing instrument introduced through an intercostal portand through the cardiac penetration. As with the annuloplasty methoddescribed above, sutures are usually applied to the valve outside of thechest, and the valve is slid along the sutures into the heart. Thesutures are then tied and trimmed. The method may further include thestep of sizing the patient's heart valve before the replacement valve isintroduced. In an exemplary embodiment, a sizing instrument isintroduced through an intercostal port and through the cardiacpenetration to measure the size of the valve annulus and to determinethe size of the replacement valve.

[0019] In order to suture the annuloplasty ring or replacement valve tothe interior of the heart, the sutures are preferably applied to theheart tissue, drawn out of the patient's body through an intercostalport and then applied to the annuloplasty ring or replacement valve. Thesutures may be radially arranged in spaced-apart locations about anorganizer ring disposed outside of the patient's body. The sutures arethen held in tension as the annuloplasty ring or replacement valve isintroduced into the interior of the heart and positioned in the naturalvalve position. The annuloplasty ring or replacement valve may beintroduced by means of a specialized holder attached to an elongatedhandle, or simply pushed along the sutures into the chest cavity bymeans of the surgeon's hands, then into the native valve position usingconventional thoracoscopic instruments such as forceps or needledrivers.

[0020] In a particularly preferred embodiment, the heart valve comprisesa mitral valve which is disposed between the left atrium and leftventricle of the patient's heart. An intercostal port is created withinan intercostal space in a right lateral portion of the patient's chest,usually within the third, fourth, or fifth intercostal space. From thisintercostal port, a cardiac penetration may be formed in the wall of theleft atrium at a location which is generally aligned with theintercostal port. In this way, surgical instruments may be introducedfrom the intercostal port in the right chest to form the cardiacpenetration, repair or excise the patient's natural valve, and/orintroduce and attach an annuloplasty ring or replacement valve.

[0021] In a further aspect of the invention, a system is provided forrepairing a heart valve. The system includes an annuloplasty device anda device holder for releasably holding the annuloplasty device tofacilitate introducing it through an intercostal port and into theheart. The device holder includes connection means for connecting theholder to an elongated handle. The connection means is configured toconnect to the handle such that the handle, holder, and annuloplastydevice together have a profile with a profile height smaller than thewidth of the intercostal space, usually less than about 30 mm andpreferably less than about 25 mm. The annuloplasty device has a bottomside which is positioned in contact with the wall of the heart aroundthe heart valve when the device is implanted. The bottom side defines afirst plane which is generally perpendicular to a longitudinal (axial)axis of the annuloplasty device. In an exemplary configuration, theconnection means connects to the handle such that the longitudinal axisof the handle forms an angle with the first plane selected so thathandle may be used to introduce the annuloplasty ring through theintercostal port without contacting or retracting the ribs adjacent theintercostal port. The angle will usually be about 0°+/−45°, andpreferably 0°+/−20°, but could also be outside of this range if theannuloplasty device is small relative to the size of the intercostalspace.

[0022] The holder also includes a means for retaining the annuloplastydevice on the holder, such as retention sutures, a retaining clip, or apivoting leaf on the holder. The system may further include means forreleasing the annuloplasty device from the holder, such as a cuttingdevice for cutting the retention sutures which hold the annuloplastydevice on the holder, or other device for releasing the mechanism whichsecures the annuloplasty device to the holder.

[0023] The annuloplasty device may be any of the commercially-availableannuloplasty rings, may be either stiff or flexible, split orcontinuous, and may have any of a variety of shapes, including C-shaped,D-shaped, kidney-shaped, saddle-shaped racetrack-shaped, oval,semi-circular, and circular. The annuloplasty device may also bemalleable or shapable into a desired shape, or may be flexible andresilient and secured in the heart in a shape which differs from itsnatural, unstressed shape.

[0024] The valve repair system may further include an elongated handlehaving a distal end mounted to the device holder and a proximal endopposite the distal end. The handle is configured to introduce theannuloplasty device into the patient's heart through an intercostalport. Preferably, the handle is at least about 20 cm in length to allowpositioning the annuloplasty device in the left atrium of the heart froma right lateral portion of the patient's chest.

[0025] The handle may also include means for pivoting the annuloplastydevice from a first orientation for introduction through the intercostalspace to a second orientation for attachment in the patient's heart. Thepivoting means is configured for actuation from a proximal end of thehandle. In this way, the annuloplasty device may be introducededge-first through the intercostal space, then pivoted about an axisgenerally perpendicular to the handle into an orientation suitable forattachment within the patient's heart, preferably wherein the firstplane is perpendicular to the longitudinal axis of the handle.

[0026] While a variety of mechanisms may be utilized for connecting theholder to the handle, in an exemplary embodiment, the handle has atongue pivotably coupled to its distal end, a movable actuator coupledto its proximal end, and a rod or cable extending through a lumen in thehandle connecting the actuator to the tongue. The tongue is received inan aperture in the device holder, and includes a spring catch or othermeans for retaining the tongue in the aperture. The aperture has an openproximal end, a distal end opposite the proximal end, and an axistherebetween defining the direction in which the tongue is received inthe aperture. The aperture is preferably oriented so that the axis formsan angle of 0°+/−45° relative to the first plane of the annuloplastydevice, facilitating introduction through an intercostal port. In thisway, the tongue may be aligned with the longitudinal axis of the handlefor edge-first introduction of the annuloplasty device through theintercostal port, then pivoted to an appropriate angle, usually about90°, relative to the handle so that the first plane of the annuloplastydevice is generally parallel to the interior wall of the heart to whichit is to be attached.

[0027] As an alternative to pivoting the annuloplasty device, theannuloplasty device and device holder may be flexible, collapsible, orcompressible so that it may be deformed or constrained into a shapewhich allows the device and holder to be introduced through anintercostal space into the thoracic cavity.

[0028] The system of the invention may also include a retraction meansfor retracting the chest wall tissue in a percutaneous penetrationwithin an intercostal space, to facilitate introduction of instruments,visualization devices, valve sizers, annuloplasty devices, andreplacement valves through the penetration without interference andwithout damaging tissue. The retraction means displaces the tissuearound the percutaneous penetration to create a small opening, but doesnot significantly retract or deflect the ribs. The retraction means maycomprise any of various types of tissue or wound retractors, but in apreferred embodiment comprises a cannula having a distal endpositionable through the intercostal space and an inner lumen ofsufficient size and shape to allow a replacement valve or annuloplastydevice to be positioned through the cannula into the chest cavity.Preferably, the inner lumen has a width of between about 12 mm and about30 mm, in order to allow the cannula to be positioned within theintercostal space with the ribs unretracted, while allowing theannuloplasty device or replacement valve to pass through the lumen withsufficient clearance. The inner lumen has a height of at least 25 mm,and usually at least 35 mm, to permit introduction of the annuloplastydevice or replacement valve. Usually, the height is larger than thewidth, in a preferred embodiment, at least about 1.5 times the width. Inthis way, the annuloplasty device or replacement valve may be introducedin an edge-first manner through the lumen of the cannula, then pivoted90° into a face-first orientation for attachment within the heart.

[0029] Because the annuloplasty device or replacement valve may beattached within the heart with a plurality of individual sutures, thesystem may further include means for organizing sutures outside of thechest cavity. The suture organizing means preferably is attached to theproximal end of the access cannula described above, and comprises aplurality of slots arranged radially about the inner lumen of thecannula. In this way, as each suture is placed in the heart tissue, thefree ends of the suture may be withdrawn through the lumen of the accesscannula and placed in one of the slots. The free ends may then be placedthrough the sewing ring of the annuloplasty device or replacement valve,and the device or valve advanced through the inner lumen of the cannulaand into the heart by sliding along the suture threads.

[0030] Preferably, the annuloplasty device is premounted to the deviceholder and the two are sterilized and packaged together in a sterilepack. In this way, the pack may be opened in the sterile operating roomenvironment with the annuloplasty device and holder ready for immediateuse. In some embodiments, the elongated delivery handle, sizing disks,access cannula or other retraction means, suture organizer, and/or othersystem components may be included in the sterile pack with theannuloplasty device and holder. Alternatively, the annuloplasty devicecould be packaged separately from the device holder and the devicemounted to the holder in the operating room at the time of the valverepair procedure.

[0031] The delivery handle of the invention is configured not only forintroducing the annuloplasty device through an intercostal port into theheart, but for introducing valve sizing devices and/or a replacementvalve as well. In this way, the same handle may be used to first sizethe native valve, then to introduce an annuloplasty device to repair themitral valve, or to introduce a replacement valve to replace the nativevalve.

[0032] Accordingly, the invention also provides a device for sizing avalve which includes both an elongated handle and a sizing disk attachedto the distal end of the handle. The sizing disk is configured toconnect to the handle in an orientation in which the handle and thesizing disk together have a profile with a profile height smaller thanthe width of the intercostal space through which the sizing disk isintroduced, usually less than about 30 mm and preferably less than about25 mm. In a preferred embodiment, the sizing disk is pivotably attachedto the handle so that it may be introduced through the intercostal spacein an edge-first orientation, and then pivoted into a face-firstorientation for sizing the valve. The handle may halve, as describedabove, a tongue pivotably mounted to its distal end which is received inan aperture on the sizing disk. allowing the sizing disk to be orientedwith its face generally parallel to the longitudinal axis of the handlefor introduction, then perpendicular to the longitudinal axis for sizingthe valve. For sizing a valve for an annuloplasty repair, the sizingdisk usually has a shape corresponding generally to the natural shape ofthe native valve annulus, which is roughly oval, kidney-shaped orD-shaped. The sizing disk also includes notches or markings to measurethe spacing between the trigones or commisures of the valve. For valvereplacement procedures, the sizing disk is preferably round,corresponding to the shape of the replacement valve sewing ring.

[0033] The invention further provides a holder for a prosthesis forrepairing or replacing a heart valve. The holder may be adapted forholding either an annuloplasty ring or a prosthetic heart valve. Theholder includes a holder body having a top, a bottom, and a holder axis.A holding means is included on the holder body for releasably holding aprosthesis such that the central axis of the attachment ring of theprosthesis is approximately parallel to the holder axis. The holderfurther includes a connection means for connecting to an elongatedhandle for introducing the holder and prosthesis through an intercostalspace. The connection means has a proximal end, a distal end, and aconnection axis therebetween. The connection means is positioned on theholder body such that the connection axis is oriented at an anglerelative to the holder axis selected so that, when the prosthesis isheld by the holding means, the profile of the prosthesis and holderperpendicular to the connection axis has a height less than the width ofthe intercostal space, usually less than about 30 mm and preferably lessthan about 25 mm.

[0034] In a preferred embodiment, as described above, the handle has apivotable tongue on its distal end, and the connection means comprisesan aperture for receiving the tongue. The aperture has an open proximalend through which the tongue is received in a direction parallel to theconnection axis. Alternatively, the connection means may comprise athreaded hole, snap fitting, luer fitting, threaded shaft, or tongueconfigured to connect to a complementary connector on the handle.Preferably, the connection means is removable from the handle to allowvalve sizers, annuloplasty rings, and replacement valves to beinterchanged on the same handle. However, the handle and holder mayalternatively be permanently inseparably interconnected for dedicateduse with a single annuloplasty device or replacement valve.

[0035] A further understanding of the nature and advantages of theinvention may be realized by reference to the remaining portions of thespecification and the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0036]FIG. 1 is a perspective view of a delivery handle for a cardiacvalve sizer, annuloplasty ring, or valve prosthesis constructed inaccordance with the principles of the present invention.

[0037]FIG. 2 is a perspective view of a distal portion of the deliveryhandle of FIG. 1.

[0038]FIG. 3 is a side cross-sectional view of the delivery handle ofFIG. 1 with a holder coupling at the distal end of the delivery handlein a longitudinally-aligned orientation.

[0039]FIG. 4 is a side cross-sectional view of the delivery handle ofFIG. 1 with a holder coupling at the distal end of the delivery handlepivoted into a transverse orientation.

[0040] FIGS. 5A-5C are perspective, front and side views respectively ofan annuloplasty ring holder constructed in accordance with theprinciples of the invention.

[0041]FIGS. 6A, 7A, and 8A are top elevational views of variousembodiments of an annuloplasty device constructed in accordance with theprinciples of the present invention.

[0042]FIGS. 6B, 7B, and 8B are perspective views of various holders forthe annuloplasty devices of FIGS. 6A, 7A, and 8A, respectively.

[0043]FIGS. 6C, 7C and 8C are perspective views of the holders of FIGS.6B, 7B, and 8B holding the annuloplasty devices of FIGS. 6A, 7A, and 8A,and attached to a distal portion of the delivery handle of FIG. 1.

[0044]FIGS. 9A, 9B and 9C are side cross-sectional views of variousalternative embodiments of annuloplasty device holders constructedaccording to the principles of the invention, schematically illustratingthe introduction of the holder through an intercostal space between tworibs.

[0045] FIGS. 10A-10D are bottom, side transverse cross-sectional, fronttransverse cross-sectional, and top views, respectively, of anannuloplasty ring and holder according to the invention in analternative embodiment thereof, a pair of ring retention leafs of theholder being in a closed position.

[0046] FIGS. 10E-10F are bottom and front transverse cross-sectionalviews, respectively, of the annuloplasty ring and holder of FIGS.10A-10D with the ring retention leafs in an open position.

[0047]FIG. 10G is a perspective view of a leaf actuation instrument formoving the ring retention leafs of the holder of FIGS. 10A-10F.

[0048]FIG. 11A is a perspective view of an annuloplasty ring and holderaccording to the invention in a further alternative embodiment thereof,with a ring retaining leaf of the holder in an open position.

[0049]FIG. 11B is a perspective view of the annuloplasty ring and holderof FIG. 11 A with the ring retention leaf in a closed position.

[0050]FIG. 11C is a front view of the holder of FIGS. 11A-11B with thering retention leaf in a closed position.

[0051] FIGS. 12A-12B are perspective views of two embodiments of anannuloplasty ring holder assembly according to the invention.

[0052] FIGS. 13A-13C are front, top and side views, respectively, of anadaptor for an annuloplasty ring holder in accordance with theinvention.

[0053] FIGS. 14A-14C are front, top and side views, respectively, of anadditional embodiment of an adaptor for an annuloplasty ring holder inaccordance with the invention.

[0054] FIGS. 15-18, 19A and 20A are side views of an annuloplasty ringon a holder and a distal portion of a delivery handle in variousalternative embodiments thereof.

[0055]FIGS. 19B and 20B are top views of the distal portion of thedelivery handle of FIGS. 19A and 20A, respectively.

[0056]FIGS. 21 and 22 are perspective views of an annuloplasty ringsizing disk and sizing disk assembly, respectively, constructed inaccordance with the principles of the invention.

[0057]FIG. 23 is a perspective view of a replacement valve sizing diskconstructed according to the invention.

[0058] FIGS. 24A-24B are perspective views of the sizing disk of FIG. 23attached to the delivery handle of FIG. 1, in two alternativeorientations.

[0059]FIG. 25 is a perspective view of a sizing disk assemblyconstructed according to the invention.

[0060]FIG. 26A-26C are perspective, top and front views, respectively,of a holder for a prosthetic valve constructed in accordance with theprinciples of the invention.

[0061]FIG. 27 is a front view of the prosthetic valve of FIGS. 26A-26Cillustrating the pivoting of distal and proximal pieces thereof.

[0062]FIG. 28 is a perspective view of a prosthetic valve which may beheld by the holder of FIGS. 26A-26C.

[0063]FIG. 29 is a perspective view of the prosthetic valve of FIG. 28held on the holder of FIG. 27.

[0064] FIGS. 30A-30B are front views of the holder and prosthetic valveof FIG. 29 attached to the delivery handle of FIG. 1, in two alternativeorientations.

[0065] FIGS. 31-34 are side views of a prosthetic valve holder and adistal portion of a delivery handle in various alternative embodimentsthereof.

[0066]FIG. 35 is an anterior partially cut-away view of a patient'schest illustrating forming an opening in the pericardium according to acardiac valve treatment method of the invention.

[0067] FIGS. 36A-36D are perspective, side, front and top views,respectively, of an oval port constructed in accordance with theprinciples of the invention.

[0068]FIG. 37A is a side view of an obturator for the oval port of FIGS.36A-36D.

[0069]FIG. 37B is a side view of the obturator of FIG. 37A positioned inan inner lumen of the oval port of FIGS. 36A-36D.

[0070]FIG. 38 is an elevational view through the oval port of FIGS.36A-36D positioned in a right lateral location of a patient's chestshowing the formation of an atriotomy according to the method of theinvention.

[0071]FIG. 39 is a perspective view of a patient illustrating therefraction of the atriotomy and positioning of a valve sizing accordingto the method of the invention.

[0072]FIG. 40 is an elevational view through the oval port of FIGS.36A-36D positioned in a right lateral location of a patient's chestshowing the placement of sutures near the mitral valve according to themethod of the invention.

[0073]FIG. 41 is a perspective view of a patient illustrating theplacement of sutures through the annuloplasty ring according to themethod of the invention.

[0074]FIG. 42 is a transverse cross-section of a patient's thoraxshowing the introduction of the annuloplasty ring through an intercostalport according to the method of the invention.

[0075]FIG. 43 is a transverse cross-section of a patient's thoraxshowing the pushing of suture knots through an intercostal port forsecuring the annuloplasty ring within the heart according to the methodof the invention.

[0076]FIG. 44 is an elevational view through the oval port of FIGS.36A-36D positioned in a right lateral location of a patient's chestshowing the pushing of suture knots against the annuloplasty ring andtrimming the ends of the sutures according to the method of theinvention.

[0077] FIGS. 45A-45B are side elevational views of a valve seatingdevice and a leaflet testing device, respectively, constructed inaccordance with the principles of the invention.

[0078]FIG. 46 is an elevational view through the oval port of FIGS.36A-36D positioned in a right lateral location of a patient's chestshowing the closure of the atriotomy according to the method of theinvention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0079] The present invention provides various devices and systems forless-invasive surgical treatment of cardiac valves, and methods of usingthe devices and systems. The systems may be adapted either for cardiacvalve repair, wherein a prosthetic annuloplasty ring is attached to aninternal wall of the heart around the native valve annulus, or forcardiac valve replacement, wherein the native valve is replaced with areplacement valve, usually a prosthetic valve. The system includes, asdescribed in detail below, a delivery handle for positioning the repairor replacement prosthesis through an intercostal space and into theinterior of the heart, and a prosthesis holder, preferably attached tothe end of the delivery handle, for releasably holding the repair orreplacement prosthesis. In various embodiments, the system may includethe repair or replacement prosthesis itself, devices for sizing thenative valve, devices for retracting tissue within an intercostal spaceto facilitate introduction of the prosthesis, devices for organizing thesutures used to attach the prosthesis within the heart, and othercomponents. Each of these components will now be described, followed bya description of a preferred method of using the system in a patient.

[0080] The system and method of the invention facilitate repairing orreplacing a cardiac valve without requiring a median sternotomy or othergross thoracotomy, and without the substantial retraction of the ribscommon in conventional open-chest valve treatment procedures. Toaccomplish this, the system is configured to operate through“intercostal ports,” which, as discussed above, is used herein toinclude small incisions, punctures, or other types of percutaneouspenetrations positioned in the intercostal spaces of the rib cage withthe ribs in their natural, substantially unretracted positions.Cannulae, trocars, or other types of tissue retraction devices may bepositioned in the percutaneous penetrations to facilitate introductionof instruments, visualization devices, prostheses, and the like, butthese will generally be limited in size to the width of the intercostalspace (e.g. less than about 30 mm), and will not require retraction ofthe ribs. In some cases, a slightly oversized cannula or retractor maybe used, but even in these cases retraction of the ribs will be limitedto less than about one centimeter. In this way, the pain, trauma, andcomplications associated with rib removal and/or gross rib retractionmay be eliminated.

[0081] FIGS. 1-4 illustrate a delivery handle for delivering aprosthesis mounted on a holder through an intercostal space and into theinterior of the heart. As shown in FIG. 1, delivery handle 10 comprisesa shaft 20 having a distal end 22 and a proximal end 24. A holdercoupling 26 is mounted to distal end 22, and a handle 28 is mounted toproximal end 24. A slidable actuation button 30 is mounted to handle 28and is linked to holder coupling 26 as described below, so that movingactuation button 30 pivots holder coupling 26.

[0082] As shown in FIG. 2, in a preferred embodiment, holder coupling 26comprises a base 32 mounted to distal end 22 of shaft 20. A bifurcatedtongue 34 is pivotably mounted to base 32 by a transverse pin 36. A rod35 extends through a lumen 37 in shaft 20 and is pinned to tongue 34 bya second transverse pin 39. A leaf spring 38 has a proximal crosspiece40 attached to tongue 34, and a free distal end 42 to which is attacheda catch 44 stepped outwardly and upwardly from leaf spring 38 to definea proximally-facing surface 46. Catch 44 serves to retain a prosthesisholder on holder coupling 26, as described below.

[0083] Shaft 20 and holder coupling 26 are configured for positioningthrough an intercostal port into the chest cavity (without retractingthe ribs), and preferably have a cross-sectional of width less thanabout 30 mm. In an exemplary embodiment, shaft 20 is about 4-8 mm indiameter, and tongue 34 has a transverse width of about 4-6 mm and atransverse height of about 0.5-2.0 mm. Shaft 20 has a length selected sothat holder coupling 26 may be positioned within the heart near thenative valve to be repaired or replaced, with shaft 22 extending throughthe desired intercostal port and handle 28 disposed outside of thepatient's chest. In a preferred embodiment, shaft 20 is configured toreach the mitral valve, disposed between the left atrium and leftventricle of the heart, from an intercostal port in the right lateralside of the patient's chest between the second and sixth intercostalspaces. For most cases, shaft 20 has a length of at least about 20 cm,and preferably at least about 30 cm, but may vary according to patientsize and according to the valve to be repaired and the approach taken toaccess the valve. Shaft 20, handle 28, and holder coupling 26 arepreferably made of stainless steel, titanium, aluminum, or a stiffbiocompatible polymer.

[0084] Referring now to FIGS. 3-4, rod 35 extends proximally from holdercoupling 26 through lumen 37 of shaft 20 into the interior 50 of handle28, where it is attached to a lower portion of actuator button 30. Rod35 is thus axially movable in tandem with actuator button 30. A lockbutton 52 is slidably mounted within a bore 54 in actuator button 30 andis biased upward by a coil spring (not illustrated). Lock button 52includes an annular flange 56 having a tapered upper edge which engagesan inner surface 58 of handle 28, holding lock button 52 in a downwardposition when actuator button 30 is in the proximal position of FIG. 3.When actuator button 30 is slid distally to the position of FIG. 4,flange 56 is aligned with an aperture 59, allowing lock button 52 to beurged upward. In this position, actuator button 30 is prevented frommoving proximally due to the engagement of flange 56 with a proximalsurface 60 of aperture 59 (best seen in FIG. 3). When it is desired toreturn actuator button 30 to the proximal position, lock button 52 ispushed downward until flange 56 clears proximal surface 60, allowingactuator button 30 to slide proximally. It should be noted that varioustypes of actuators may be used for translating rod 35, such as levers,rotatable knobs, and push buttons. Moreover, the provision of lockbutton 52 is optional, and in some cases it may be more desirable toeliminate lock button 52 so that actuator button 30 is free to movedistally and proximally without locking. Lock button 52 could also beconfigured to lock actuator button 30 in both the proximal and distalpositions, or in various intermediate positions.

[0085] When actuator button 30 is in the proximal position of FIG. 3,holder coupling 26 is preferably longitudinally aligned with thelongitudinal axis of shaft 20. In this position, holder coupling 26 andshaft 20 have a transverse profile small enough that a prostheticannuloplasty ring or valve on a holder, when mounted to holder coupling26 as described below, may be positioned through an intercostal portinto the chest cavity. Depending upon patient anatomy, patient size,prosthesis holder configuration, and prosthesis size, holder coupling 26could be oriented at a range of angles between about 0° and 45° relativeto the longitudinal axis of shaft 20 and still allow the prosthesis andholder to introduced through an intercostal port without significantretraction of the ribs.

[0086] When rod 35 is translated distally by moving actuator button 30,holder coupling 26 pivots about pin 36 through an angle θ relative tothe longitudinal axis of shaft 20, as shown in FIG. 4. In order toorient a prosthetic annuloplasty ring or valve optimally for attachmentwithin the heart, angle θ is preferably about 90°, however, angle θ maybe any angle between about 45° and 135°, depending upon the particularvalve being repaired or replaced, the location and size of theintercostal port through which delivery handle 10 is introduced, and theanatomy of the patient.

[0087] A cleaning port 62 is disposed in shaft 20 in communication withinner lumen 37 to facilitate delivery of a cleaning fluid into theinterior 50 of shaft 20 and handle 28. A plurality of drain holes 64 areprovided in the lower side of handle 28 to allow cleaning fluid to drainfrom the handle.

[0088] Holder coupling 26 is adapted for attachment to a valve sizingdevice or to a holder for a prosthetic annuloplasty ring or replacementvalve. An exemplary embodiment of a holder for a prosthetic annuloplastyring according to the invention is illustrated in FIGS. 5A-5C. Holder 70includes a holder body 72 having an outer edge 74 with a shape selectedto match that which the annuloplasty ring is to assume when securedwithin the heart, such as D-shaped, C-shaped, kidney-shaped,semicircular, oval, or circular. A groove or channel 76 having an upperflange 73 extends around outer edge 74 on the lateral side of holderbody 72 and has a size and shape selected to receive the annuloplastyring in order to hold the annuloplasty ring on holder, body 72. One ormore suture holes 77 extend through holder body,72 through which asuture may be threaded and tied around the annuloplasty ring to secureit to the holder. A groove or ridge 75 extends across top surface 78transverse to the direction in which the retention sutures would be tiedto holder 70. In this way, a knife may be guided by groove or ridge 75to cut the sutures to release the ring from holder 70. Holder body 72has a top surface 78 on which is disposed a handle coupling 80. In anexemplary embodiment, handle coupling 80 comprises a slot 82 configuredto receive holder coupling 26 on delivery handle 10. Slot 82 has an openproximal end 84 and an open distal end 86. Holder coupling 26 isreceived into slot 82 through proximal end 84 and slides into slot 82until catch 44 extends outside of slot 82 through distal end 86, asdescribed more fully below.

[0089] Various exemplary annuloplasty rings which may be utilized inconjunction with holder 70 are illustrated in FIGS. 6A, 7A, and 8A. Theannuloplasty rings preferably comprise a flexible, stiff, or deformablesupport ring covered by a fabric or mesh suitable for suturing theannuloplasty ring to heart tissue. The support ring may be abiocompatible metal such as stainless steel or titanium or a flexiblematerial such as silicone rubber or Dacron cordage, depending upon thestructural,, and performance characteristics desired in the ring. Theoverlying fabric or mesh may be a polyester knit fabric, polyestervelour cloth, expanded polytetrafluoroethylene, or other biocompatibleporous material with sufficient structural integrity to resist tearingwhen a suture is passed through it and secured to the heart. Holder 70may be adapted for use with any of the various commercially availableannuloplasty rings, including the Carpentier-Edwards™ Mitral Ring, theCarpentier Physio™ Ring, or Cosgrove™ Ring available from BaxterHealthcare Corp., Edwards CVS Div., Irvine, Calif., the Sculptor™ orDuran™ Ring available from Medtronic, Inc. of Minneapolis, Minn., thePuig Massana™ Ring available from Sorin Biomedica of Salaggia, Italy, orthe Biflex™ Ring available from St. Jude Medical, Inc. of St. Paul,Minn. Holder 70 is configured to hold annuloplasty rings of variousshape and size. FIG. 6B illustrates a holder 70′ adapted for holding theD-shaped split annuloplasty ring 90′ shown in FIG. 6A, such as theBaxter, Inc. Carpentier-Edwards Mitral Ring. In FIG. 6C, annuloplastyring 90′ is mounted to holder 70′, which is attached to holder coupling26 of delivery handle 10. FIG. 7B illustrates a holder 70″ adapted forholding the D-shaped continuous annuloplasty ring of FIG. 7A, such asthe Baxter Carpentier Physio™ Ring, or the Medtronic Sculptor™ Ring.FIG. 7C shows annuloplasty ring 90′″ mounted to holder 70′″, which isattached to holder coupling 26 of delivery handle 10. FIG. 8Billustrates a holder 70′″ adapted for holding the C-shaped split or openannuloplasty ring 90′″ of FIG. 8A, which may be the Baxter Cosgrove™Ring. FIG. 8C illustrates holder 70′″ holding annuloplasty ring 90′″ andmounted to holder coupling 26 of delivery handle 10. Annuloplasty ringsof various other shapes may also be used with the holder of theinvention, including kidney-shaped, saddle-shaped racetrack-shaped,semicircular, circular, and others. In some cases, the annuloplasty ring90 may be flexible and may have a shape in a natural, unstressedcondition which is different than the shape of holder 70. For example, acircular ring could be held by a D-shaped holder. In this way, the ringconforms to the shape of holder 70 and is held in the shape it will bein when secured within the heart. Ring 90 may also be shapable ormalleable so that it may shaped into the shape of holder 70 and/orreshaped when secured within the heart.

[0090] As shown in FIG. 6A, annuloplasty ring 90′ has a transverseheight RH and a transverse width RW. In many cases, both transverseheight RH and transverse width RW will be larger than the width of theintercostal space through which they are to be introduced. When mountedto holder 70, handle coupling 80 is adapted to receive holder coupling26 such that an annuloplasty ring 90 can be attached to delivery handle10 and introduced through an intercostal port without retraction of theadjacent ribs. In a preferred embodiment, slot 82 is parallel to abottom side 88 of holder body 72, which is generally parallel to theplane contacting the bottom side of the annuloplasty ring when attachedto holder 70. Such a configuration is illustrated in FIG. 9A, whichschematically illustrates shaft 20 of delivery handle 10 positioningholder 70, to which is mounted an annuloplasty ring 90, within anintercostal space I between two ribs R (chest wall tissue is not shownfor simplification). It may be seen that, when holder coupling 26 islongitudinally aligned with shaft 20, the bottom side 88 of holder 70,along with the plane containing the bottom side of annuloplasty ring 90.are parallel to the longitudinal axis of shaft 20 Alternatively stated,the longitudinal (or axial) axis of annuloplasty ring 90 isperpendicular to the longitudinal axis of shaft 20. In thisconfiguration, holder 70, annuloplasty ring 90 and delivery handle 10have a transverse profile of minimum size to facilitate introductionthrough intercostal space I. In most adult patients, intercostal space Iwill have a width W between about 20 mm and 30 mm in the right lateralchest at the locations suitable for approaching the mitral or tricuspidvalve. Thus, with annuloplasty ring 90 mated to holder 70, thetransverse height H between the bottom and top sides of holder 70,including the diameter shaft 20, will be less than about 30 mm, andpreferably less than about 20 mm.

[0091] In addition to the configuration shown in FIG. 9A, handlecoupling 80 of holder 70 may have various alternative configurations,two of which are shown in FIGS. 9B and 9C. In the embodiments of FIGS.9B-9C, slot 82 is oriented at an angle α relative to bottom side 88 ofholder body 72 (and the plane containing the bottom of annuloplasty ring90 and perpendicular to the longitudinal axis of annuloplasty ring 90.Angle α is selected so that holder 70, with annuloplasty ring 90 mountedto it, may be attached to holder coupling 26 on shaft 20 and introducedthrough intercostal space I without retracting ribs R. Angle a may beeither positive or negative relative to slot 82 (and the longitudinalaxis of shaft 20), and is usually within a range of −45° to +45°, andpreferably −20° to +20°. The height H of holder 70 perpendicular tobottom surface 88 will be substantially less than intercostal width W,usually less than about 25 mm, and preferably less than about 20 mm, sothat some clearance is provided between holder 70 and the ribs Rdefining the intercostal space I. Once the holder and annuloplasty ringare through the intercostal space, delivery handle 10 may be manipulatedand holder coupling 26 pivoted so that annuloplasty ring 90 is in anorientation suitable for advancement into and attachment within theheart, as described more fully below.

[0092] It should be noted that in some cases intercostal width W may besufficiently large and the annuloplasty ring diameter (or width acrossthe ring) sufficiently small that angle α could be as great as 900°—thatis, bottom surface 88 (or the plane of ring 90) could form a right anglerelative to the longitudinal axis of shaft 20—and ring 90 could still bepositioned through the intercostal space without retracting the ribssignificantly. However, in most cases it will be advantageous to orientthe ring at an angle somewhat less than 90° relative to the longitudinalaxis of shaft 20 to provide maximum clearance relative to the adjacentribs and to allow the ring to be introduced through an intercostal portof minimum size.

[0093] FIGS. 10A-10G illustrate a further embodiment of an annuloplastyring holder according to the invention. In this embodiment, holder 420includes a holder body 422 having a top surface 424 and a bottom surface426. A handle coupling 428 is mounted to top surface 424, and includesan axial slot 430 for receiving holder coupling 26 on delivery handle10. A flange 432 extends around the top lateral edge of holder body 422.An annuloplasty ring 434, which may have various shapes, stiffnesses,and materials, is positionable around the lateral edge of holder body422 abutting flange 432. A pair of ring retention leafs 436 arerotatably coupled to holder body 422 by a bearing 438 so as to berotatable about an axis parallel to the longitudinal axis ofannuloplasty ring 434. Each ring retention leaf 436 has a pair ofapertures 440 in a top surface thereof for engagement by a leafactuation instrument 442, shown in FIG. 10G. Leaf actuation instrument442 has an elongated shaft 444 long enough to reach the native valveposition in the heart from outside of the chest cavity (e.g. about 30cm), and a pair of prongs 446 at its distal end for insertion intoapertures 440 in ring retention leafs 436. A stop 448 extends downwardlyfrom bottom surface 426 of holder body 422 to limit the rotation of ringretention leafs 436 beyond the open and closed positions. A lip 449extends from bottom surface 426 to help retain ring 434 against flange432. In this way, ring retention leafs 436 may be placed in the openposition of FIGS. 10E-10F for placement of annuloplasty ring 434 onholder 420, and, using leaf actuation instrument 442, leafs 436 may berotated into the closed position of FIGS. 10A-10C to trap ring 434between leafs 436 and flange 432. After annuloplasty ring 434 has beensecured around the native valve within the heart, leaf actuationinstrument 442 may be introduced through an intercostal port andinserted into apertures 440 to rotate ring retention leafs 436 into theopen position, releasing ring 434 from holder 420.

[0094] An additional embodiment of an annuloplasty ring holder accordingto the invention is shown in FIGS. 11A-11C. Holder 450 comprises aholder body 452 having a top surface 454 and a bottom surface 456. Ahandle coupling 458 is mounted to top surface 454 and includes an axialslot 460 for receiving holder coupling 26 on delivery handle 10. Aflange 462 extends around the top lateral edge of holder body 452, and agroove or channel 464 extends around the lateral side of holder body 452on a rearward portion thereof. An annuloplasty device 466, which againcould be of various shapes, stiffnesses, and materials, may bepositioned around holder body 452 in channel 464, so as to abut flange462. A ring retention leaf 468 is hingedly mounted to bottom surface 456by a suitable coupling means, such as a living hinge 470 or by a pinnedhinge joint, whereby ring retention leaf 468 may be pivoted between theopen position of FIG. 11A to the closed position of FIGS. 11B-11C. Apair of tabs 472 extend from an outer edge of ring retention leaf 468such that, when leaf 468 is in the closed position of FIG. 11B, ring 466is trapped between tabs 472 and flange 462. Ring retention leaf 468 isretained in the closed position by a pair of flexible catches 474 whichmay be deflected toward each other by applying a laterally-directedforce. Each catch 474 has a tapered distal end 476 leading proximally toa step 478. Ring retention leaf 468 has a central opening 480 throughwhich catches 474 may extend when leaf 468 is in the closed position,and a shelf 482 for engaging steps 478 to retain leaf 468 in the closedposition. Thus, when leaf 468 is pivoted from the open position to theclosed position, the tapered distal ends of catches 474 engage leaf 468at the edge of opening 480 and are urged inwardly as the leaf is closed.When leaf 468 is completely closed, steps 478 clear shelf 482 andcatches 474 spring outwardly so that steps 478 engage shelf 478,maintaining leaf 468 in the closed position. After annuloplasty ring 466has been secured around the native valve in the heart, thoracoscopicforceps or other elongated grasping device may be introduced through anintercostal port and used to squeeze catches 474 together, allowing leaf468 to open and releasing annuloplasty ring 466 from holder 450.

[0095] Two additional embodiments of an annuloplasty ring holderassembly according to the invention are illustrated in FIGS. 12A-12B. Inthese embodiments, holder assemblies 100, 101 comprise a holder 102, 103similar to the holders used with commercially-available annuloplastyrings, and an adaptor 104, 105 for attaching holder 102 to deliveryhandle 10. Holder 102,103 is in some respects similar to holder 70 ofFIGS. 5A-C, with the exception that, in place of handle coupling 80 ofholder 70, holder 102,103 has a hole 106, as in FIG. 12A, or a post 108,as in FIG. 12B, adapted for attachment to a conventional handle for usein open heart surgery. Hole 106 and post 108 are designed to attach tosuch a conventional handle in an orientation in which at least a distalportion of the handle is perpendicular to the top surface 110, 111 andbottom surface 112, 113 of holder 102, 103 (and the plane of theannuloplasty ring held by the holder). The longitudinal axes of hole 106and post 108 are thus perpendicular to surfaces 110, 111, 112, 113. Agroove or channel 114, 115 extends around the lateral edge of each ofholders 102, 103 and is configured to receive an annuloplasty ring.

[0096] Adaptors 104, 105, illustrated more clearly in FIGS. 13A-C and14A-C, facilitate the attachment of a conventional angioplasty ringholder to delivery handle 10 of the invention. Adaptor 104 includes adownward-extending distal fitting 116 configured for insertion into ahandle attachment hole in a holder like holder 102 of FIG. 12A. Adaptor104 further includes a proximally-extending proximal fitting 118 forattachment to holder coupling 26 of delivery handle 10. Distal fitting116 comprises a cylindrical member 120 with an annular groove 122 inwhich an O-ring 124 is disposed. Cylindrical member 120 may be insertedinto hole 106 in holder 102 and is retained therein by O-ring 124.Alternatively, for annuloplasty ring holders having a threaded handleattachment hole, cylindrical member 120 may have external threads tocouple to the threaded hole. In a preferred embodiment, proximal fitting118 comprises a slot 126 having an open proximal end 128 through whichholder coupling 26 is received and an open distal end 130 through whichcatch 44 may extend. As shown in FIG. 13C, the longitudinal axis of slot126 is preferably perpendicular to the longitudinal axis of cylindricalmember 120. However, as with holder 70 described above in connectionwith FIGS. 10 and 11, slot 126 may be at a variety of angles relative tocylindrical member 120 so long as the annuloplasty ring held on holder102 may be positioned through an intercostal space without significantretraction of the adjacent ribs. Usually, slot 126 is between about −45°and +45°, and preferably −20_to +20 _, relative to the longitudinal axisof cylindrical member 120.

[0097] Referring now to FIGS. 14A-14C, adaptor 105 comprises a distalfitting 132 and a proximal fitting 134. In this embodiment, distalfitting 132 is adapted to attach to post 108 on holder 103, andcomprises a cylindrical aperture 136 for receiving post 108. Cylindricalaperture 136 may include an internal O-ring (not shown) or may betapered so as to frictionally engage post 108. Alternatively, if post108 is externally threaded, aperture 136 may include internal threads toretain post 108 therein. Proximal fitting 134 preferably comprises aslot 138 having an open proximal end 140 and an open distal end 142 soas to receive holder coupling 26 of delivery handle 10 as describedabove in connection with adaptor 104. Again, slot 138 is preferablyperpendicular to the longitudinal axis of aperture 136, but it may be atvarious other angles depending upon the size and shape of holder 103 andthe annuloplasty ring it is designed to carry.

[0098] While only two configurations of the adaptor and holder assemblyof the invention are shown in FIGS. 12-14, it will be understood bythose of ordinary skill in the art that various other configurations arepossible to adapt virtually any of the annuloplasty ring holderscurrently available for attachment to delivery handle 10 of theinvention. In most cases, this will simply require adapting the distalfitting of the adaptor for the particular handle attachment meansutilized on the ring holder.

[0099] Although the foregoing embodiments of holder 70 and adaptors 104,105 have been shown as having a handle coupling in the form of a slotfor receiving tongue 34 of delivery handle 10, various other types ofhandle/holder couplings may also be utilized. Various exemplaryembodiments are illustrated in FIGS. 15-20. In the embodiments of FIGS.15 and 16, holder coupling 26 on delivery handle 10 comprises a threadedaperture 150, and handle coupling 80 on holder 70 comprises a threadedshank 152 which may be threaded into aperture 150. In FIG. 15, thelongitudinal axis of threaded shank 152 is parallel to holder body 72,while in FIG. 16, the longitudinal axis of threaded shank 152 isdisposed at an angle relative to holder body 72, preferably between −45°and +45°. In FIGS. 17 and 18, holder coupling 26 comprises a threadedshank 154, and handle coupling 80 comprises a threaded aperture 156. Thelongitudinal axis of threaded aperture 156 may be parallel to holderbody 72 as in FIG. 17, or at an angle similar to threaded shank 152 ofFIG. 16. Alternatively, the longitudinal axis of threaded aperture 156may be perpendicular to holder body 72 as in FIG. 18, and threaded shank154 may be mounted to shaft 20 so that the longitudinal axis of threadedshank 154 is perpendicular to shaft 20.

[0100] In the embodiment of FIGS. 19A-B, holder coupling 26 comprises ajaw 158 having a pair of resilient, arcuate jaw members 160 forming aC-shape. Handle coupling 80 comprises a cylindrical post 162 with anannular channel 164 formed therein which is configured to receive jaw158. In this way, jaw 158 is attached to post 162 by sliding jaw members160 around post 162 within annular channel 164. Jaw 158 is slightlyundersized relative to post 162, such that jaw members 160 flexoutwardly as they are inserted into annular channel 164 and exert aninward force on post 162 to maintain a tight grip thereon.

[0101] In still another embodiment, holder coupling 26, comprises abayonet fitting 166 having a cylindrical body 168 and a pair of radiallyextending tabs 170. Handle coupling 80 comprises a cylindricalreceptacle 172 having a pair of helical slots 174 in its sidewall forreceiving tabs 170. In this way, bayonet fitting 166 may be insertedinto receptacle 172 and twisted to form a tight attachment.

[0102] It should be understood that the above are only some of thepossible configurations for holder coupling 26 and handle coupling 80,and should not be taken to limit the range of possible interconnectionsbetween holder 70 and delivery handle 10. In addition to those describedabove, other possible connection means include luer fittings, snapfittings, spring-loaded catches, magnetic attachments, movable jaws ondelivery handle 10 for grasping holder 70, and various others. Inaddition, holder 70 may be permanently and non-removably attached todelivery handle 10.

[0103] In order to select an annuloplasty ring of the correct size forthe valve being repaired, the native valve must be sized. Sizing disksmay be used for this purpose. As will be described more fully below,sizing disks of various sizes are positioned adjacent the native valveto be repaired until a disk of the proper size is identified. Anannuloplasty ring of a corresponding size is then selected forattachment around the native valve. A similar technique is used forsizing a native valve for replacement with a prosthetic valve.Advantageously, the present invention provides devices and methods forsizing a native valve which may be utilized through an intercostal port,without retraction or removal of ribs. FIG. 21 illustrates a preferredembodiment of a sizing disk according to the invention. Sizing disk 180comprises a disk body 182 shaped similarly to the native valve annulusand having and having an upper face 183 and a lower face 185. Disk body182 is preferably a transparent material such as polysulfone orpolycarbonate such that the native valve is visible when the sizing diskis positioned in front of it. Two or more notches 184 or other markingsmay be disposed along a side of sizing disk 180 to facilitate measuringthe spacing of the native valve trigones-or commissures. Sizing disk 180also includes a handle coupling 186 for attaching the sizing disk todelivery handle 10. Handle coupling 186 comprises, in a preferredembodiment, a slot 188 having an open proximal end 190 and an opendistal end 192. Holder coupling 26 of delivery handle 10 is receivedinto slot 188 through proximal end 190 and catch 44 extends out of slot188 through distal end 192. Slot 188 is disposed at an angle relative todisk body 182 selected to allow sizing disk 180 to be introduced throughan intercostal space using delivery handle 10 without retraction orremoval of ribs. Usually the longitudinal axis of slot 188 is between−45° and +45°, and is preferably parallel to, upper and lower faces 183,185 of disk body 182. With this configuration, sizing disk 180 may beattached to holder coupling 26 of delivery handle 10 and introducedthrough an intercostal port with disk body 182 generally parallel to thelongitudinal axis of shaft 20. Once within the chest cavity, sizing disk180 may be pivoted relative to shaft 20 into a perpendicular orientationsuch that the disk face is parallel to the native valve for themeasurement thereof. Of course, like holder 70, handle coupling 186 mayhave a variety of other configurations, such as those of handle coupling80 described above in connection with FIGS. 15-20.

[0104] A second embodiment of a native valve sizer according to theinvention is illustrated in FIG. 22. In this embodiment, sizing disk 194may be any of a variety of commercially-available sizing disks for usewith the annuloplasty rings currently used in open heart surgery. Sizingdisk 194 has a disk body 196 with an upper face 198 and a lower face200. Two or more notches 202 or other markings may be provided on a sideof disk body 196 for measurement of a native valve leaflet. A hole 204is disposed in a central region of disk body 196 for attachment of thesizing disk to a conventional handle for use in open heart surgery. Anadaptor 206 is further provided for attaching sizing disk 194 todelivery handle 10. In a preferred embodiment, adaptor 206 has aconfiguration like adaptor 104 described above in connection with FIGS.12-14. Adaptor 206 has a cylindrical member 208 extending downwardly andconfigured for insertion into hole 204. Cylindrical member 208 mayinclude an O-ring 210 for securing the cylindrical member within hole204. Alternatively, if hole 204 has internal threads, cylindrical member208 may have external threads. Other types of interconnections may alsobe used, such as a cylindrical aperture on adaptor 206 designed toreceive a post or shank on sizing disk 194, like that described above inconnection with holder 103 of FIG. 12B. Adaptor 206 also has a handlecoupling 212, which preferably comprises a slot 214 for receiving holdercoupling 26 of delivery handle 10. Slot 214 is preferably perpendicularto the longitudinal axis of cylindrical member 208, so as to be parallelto the upper and lower faces 198, 200 of sizing disk 194 when connectedto it. Slot 214 may be disposed at other angles as well, so long assizing disk 194, when connected to adaptor 206 and delivery handle 10,may be introduced through an intercostal port without removing orsignificantly retracting the ribs. As with sizing disk 180 of FIG. 21,various other handle coupling configurations may also be utilized onadaptor 206.

[0105] For cases in which valve repair is inappropriate, the inventionalso provides devices and methods for sizing a native valve which is tobe replaced with a prosthetic valve. A replacement valve sizing diskaccording to the invention is illustrated in FIG. 23. Valve sizing disk220 includes a disk body 222 having an upper face 224 and a lower face226. Disk body 222 has a shape corresponding to that of the prostheticvalve to be used for replacing the native valve, and is usuallycircular. A handle coupling 228 is mounted to upper face 224. Handlecoupling 228 preferably comprises a slot 230 configured to receiveholder coupling 26 of delivery handle 10. Slot 230 has an open proximalend 232 through which coupling member 26 is received, and an open distalend 234 through which catch 44 may extend. The longitudinal axis of slot230 is preferably parallel to upper and lower faces 224, 226 of diskbody 222, but may be at other angles, usually between about −45° and+45°, so long as sizing disk 220, when attached to coupling means 26 ofdelivery handle 10, may be introduced through an intercostal spacewithout retraction or removal of ribs. A multitude of alternativeconfigurations for handle coupling 228 are also possible, includingthose described above in connection with FIGS. 15-20.

[0106] When sizing disk 220 is attached to delivery handle 10 andpositioned in the orientation of FIG. 24A, upper and lower faces 224,226 are parallel to the longitudinal axis of shaft 20, and the combinedprofile of sizing. disk 220 and shaft 20 is minimized to facilitateintroduction through an intercostal port. Once positioned within thechest cavity, sizing disk 220 may be pivoted into the orientation ofFIG. 24B, wherein faces 224, 226 are generally perpendicular to thelongitudinal axis of shaft 20. In this orientation, sizing disk 220 maybe positioned so that lower face 226 is facing the native valve to allowsizing disk 220 to be pushed in and out of and/or positioned within thenative valve annulus to compare the native annulus size to the sizingdisk size. This process is repeated using sizing disks of variousdiameters until the proper size is determined.

[0107]FIG. 25 illustrates an alternative embodiment of a sizing diskassembly according to the invention, wherein an adaptor 236 is utilizedfor attaching a conventional sizing disk 238 to delivery handle 10.Sizing disk 238 may be any of a variety of sizing disks currently in usein open heart valve replacement surgeries, and has a shape correspondingto the shape of the prosthetic valve to be used for the replacement.Sizing disk 238 has a hole 240 of rectangular cross-section suitable forattachment to a conventional handle utilized in open heart surgery.Adaptor 236 includes a rectangular tongue 242 configured for insertioninto hole 240. A leaf spring catch 244 similar to catch 44 on deliveryhandle 10 is provided on tongue 242 to retain it within hole 240.Alternatively, sizing disk 238 may have a post or shank extendingupwardly from it, in which case cylindrical member 242 may have aninternal aperture for receiving the post or shank. Adaptor 236 furtherincludes a handle coupling 246, which preferably comprises a slot 248having an open proximal end 250 for receiving holder coupling 26, and anopen distal end 252 through which catch 44 may extend. The longitudinalaxis of slot 248 is preferably perpendicular to the longitudinal axis oftongue 242 so that, when adaptor 236 is connected to sizing disk 238,the slot is generally parallel to the face of the sizing disk. In thisway, coupling member 26 of delivery handle 10 may be inserted throughslot 248 and sizing disk may be oriented so that it is parallel to thelongitudinal axis of shaft 20, thereby having a minimum profile forintroduction through an intercostal port.

[0108] Once the native valve has been sized for replacement, deliveryhandle 10 of the invention may also be used to deliver the replacementvalve into the heart for attachment at the native valve position, usingtechniques described in detail below. In order to facilitate introducingthe replacement valve through an intercostal space without retracting orremoving ribs, the invention provides a replacement valve holder havingan extremely small profile and adapted for attachment to delivery handle10. A preferred embodiment of a valve holder according to the inventionis shown in FIGS. 26A-26C. Valve holder 260 is adapted for holding amechanical bileaflet valve prosthesis as shown in FIG. 28, which may be,for example, a bileaflet mitral or aortic valve prosthesis availablefrom St. Jude Medical, Inc. of St. Paul, Minn., CarboMedics, Inc. ofAustin, Tex., or Sorin Biomedica of Saluggia, Italy. In the example ofFIG. 28, valve prosthesis 262 has an annular frame 264 and a sewing ring266 attached to frame 264 for attachment to an interior wall of theheart at the native valve position. Sewing ring 266 is covered by afabric or mesh of e.g. Dacron to allow the prosthesis to be sutured tothe heart tissue. A pair of parallel uprights 268 extend axially upwardfrom frame 264. A pair of leaflets 270 having curved outer edges 272 andstraight inner edges 274 are pivotably mounted to uprights 268. Leaflets270 are movable between a closed position, in which straight inner edges274 are contacting each other and curved outer edges are contacting theinner wall of annular frame 264, and an open position in which leafletsare spaced apart from each other and from annular frame 264. Frame 264,uprights 268 and leaflets 270 are made of a rigid biocompatible polymer,metal or graphite coated with a thrombolytic material such as pyrolyticcarbon.

[0109] Referring again to FIGS. 26A-26C, valve holder 260 comprises adistal piece 276 and a proximal piece 278 pivotably coupled together bytwo transverse pins 280, allowing distal piece 276 to pivot about atransverse axis relative to proximal piece 278, as shown in FIG. 27.Distal piece 276 has a top portion 282 which is bifurcated into twoparallel side sections 282A, 282B. Proximal piece 278 has a single topportion 284 disposed between side sections 282A, 282B. Pins 280 extendthrough side sections 282A, 282B and into top portion 284. An axial slot286 extends through top portion 284 in an axial direction, and isconfigured to receive holder coupling 26 on delivery handle 10. Axialslot 286 has an open proximal end 288 through which tongue 34 isinserted and an open distal end 290 through which catch 44 may extend. Apair of transverse suture holes 287, 289 extend through sides sections282A, 282B and through top portion 284 for tying a retention suture, asdescribed below. Distal piece 276 has a distal leg 292 extendingdownwardly from top portion 282 and having a distally-facing annularchannel 294 for receiving a portion of annular frame 264 of valveprosthesis 262. Proximal piece 278 has a proximal leg 296 extendingdownwardly from top portion 284 and having a proximally-facing annularchannel 298 for receiving a portion of annular frame 264. When legs 292,296 are pivoted into the position of FIG. 27, valve prosthesis 262 maybe positioned over the legs, which are disposed between each valveleaflet 270 and annular frame 264. Legs 292, 296 may then be pivotedoutwardly to seat annular frame 264 in channels 294, 298, as shown inFIG. 29. A suture 300 may then be tied through suture holes 287, 289 tomaintain distal piece 276 and proximal piece 278 in an outward positionto retain valve prosthesis 262 thereon.

[0110] FIGS. 30A-30B illustrate valve prosthesis 262 mounted to holder260, which is attached to holder coupling 26 of delivery handle 10. Inthe introduction position of FIG. 30A, holder coupling 26 is alignedwith the longitudinal axis of shaft 20, such that the plane containingthe lower surface of sewing ring 266 is generally parallel to thelongitudinal axis of shaft 20. Alternatively stated, the centrallongitudinal axis of valve prosthesis 262 is generally perpendicular tothe longitudinal axis of shaft 20. In this position, the overall heightH of holder 260, valve prosthesis 262, and shaft 20 is minimized tofacilitate introduction through an intercostal port, with height Husually being less than about 30 mm and preferably less than about 25mm. Of course, some deviation from this orientation may be possiblewithout hindering introduction through the intercostal port. Forexample, depending upon the size of the valve prosthesis relative to thewidth of the intercostal space, valve prosthesis 286 may be positionedas much as about +/−45° from the position of FIG. 30A duringintroduction. Once valve prosthesis 262 has been introduced through theintercostal port, it may be pivoted into an orientation suitable forattachment at the native valve position within the heart. In theattachment orientation, the central longitudinal axis of valveprosthesis 262 will preferably be parallel to the longitudinal axis ofshaft 20, such that the lower surface of sewing ring 266 is facing andparallel to the interior wall of the heart to which the valve will beattached. A variety of other angular orientations may also be used wherea non-perpendicular approach to the valve has been taken, or in otherappropriate circumstances. Advantageously, delivery handle 10 allows thevalve prosthesis to be pivoted into a wide range of angular orientationsaccording to the needs of each particular case.

[0111]FIG. 30A also illustrates an important advantage of holder 260 ofthe invention. It may be seen that distal leg 292 and proximal leg 296extend below the lower ends of valve leaflets 270. In this way, whenvalve prosthesis 262 is mounted to holder 260, leaflets 270 areprotected from damage during introduction and placement.

[0112] In the embodiment of FIGS. 26-30, valve holder 260 is attached todelivery handle 10 by means of axial slot 286 which receives holdercoupling 26 on the handle. However, it will be understood to those ofordinary skill in the art that a variety of other handle attachmentmeans may be used on the valve holder of the invention. Four exemplaryalternative handle attachment means are shown in FIGS. 31-34. In FIG.31, holder coupling 26 on handle 10 comprises an internally-threadedaperture 302, and holder 260 is attached to handle 10 by a threadedshank 304 extending proximally from proximal piece 278 which may bethreaded into aperture 302. Shank 304 may be at a variety of anglesrelative to holder. 260, but is preferably perpendicular to thelongitudinal axis of the holder. In FIG. 32, a threaded shank 306 onholder 260 on the top of proximal piece 278 is generally parallel to thelongitudinal axis of holder 260 for connection to a laterally-orientedinternally-threaded aperture 308 on holder coupling 26. In FIG. 33, athreaded shank 310 on holder coupling 26 couples to a threaded hole 312in holder 260 which is perpendicular to the longitudinal axis of theholder. In FIG. 34, a threaded hole 314 is parallel to the longitudinalaxis of the holder and connects to a laterally oriented threaded shank316 on holder coupling 26. Various other handle connection mechanismsare also possible, including bayonet fittings, luer locks, spring-loadedcatches, holder-gripping jaws on handle 10, and permanent,non-detachable linkages. The particular type of attachment means is notcritical, so long as valve holder 260 may be connected to deliveryhandle 10 in an orientation which allows valve prosthesis 262 to be heldon holder 260 and introduced through an intercostal port withoutremoving or retracting the ribs.

[0113] In addition to the bileaflet valve prosthesis illustrated in FIG.28, the prosthesis holder and delivery system may also be adapted foruse with a variety of other types of prosthetic valves, both mechanicaland bioprosthetic. Various types of prosthetic valves useful with theinvention are described in Jamieson, “Modern Cardiac ValveDevices—Bioprostheses and Mechanical Prostheses: State of the Art,” J.Card. Surg. 8:89-98 (1993). Mechanical valves which may be used includethe caged-ball type such as the Starr-Edwards™ valve (Baxter HealthcareCorp., Edwards CVS Division, Irvine, Calif.), the tilting disk type suchas the Medtronic-Hall™ valve (Medtronic, Inc., Minneapolis, Minn. ), theBjork-Shiley Monostrut™ valve (Shiley, Inc., Irvine, Calif. ), theOmniscience™ valve (Omniscience Medical, Inc., Grove Heights, Minn. ),as well as the bileaflet type such as the Baxter Duromedics™ Valve(Baxter Healthcare Corp., Edwards CVS Division, Irvine, Calif. ), St.Jude valve (St. Jude Medical Inc., St. Paul, Minn. ), Carbomedics valve(CarboMedics, Inc., Austin, Tex. ), or Sorin valve (Sorin Biomedica,Saluggia, Italy). Bioprosthetic valves which may be placed using thedevices and techniques of the invention include porcine aortic valvessuch as the Hancock II™ bioprosthesis (Medtronic, Inc., MinneapolisMinn. ), the Carpentier-Edwards™ supraannular bioprosthesis (BaxterHealthcare Corp., Edwards CVS Division, Irvine, Calif. ), theCarpentier-Edwards™ stentless bioprosthesis (Baxter Healthcare Corp.,Edwards CVS Division, Irvine, Calif. ), the St. Jude Bioimplant™bioprosthesis (St. Jude Medical Inc., St. Paul, Minn. ), or theMedtronic Intact™ bioprosthesis (Medtronic, Inc., Minneapolis, Minn. ).Other valves which may be used include the Mitroflow™ bioprosthesis(Mitroflow International, Inc., Richmond, British Columbia, Canada), andthe Carpentier-Edwards™ pericardial bioprosthesis (Baxter HealthcareCorp., Edwards CVS Division, Irvine, Calif. ). The invention alsofacilitates valve replacement with homografts and allografts, polymericvalves, and a variety of mechanical and bioprosthetic valves notspecifically listed here.

[0114] The methods of repairing and replacing a diseased heart valveaccording to the invention will now be described with reference to FIGS.35-46. The patient must first be prepared for surgery by inducinggeneral anesthesia, establishing cardiopulmonary bypass, and inducingcardioplegic arrest. Devices and techniques for inducing cardioplegicand establishing cardiopulmonary bypass which may be used in conjunctionwith the method of the present invention are described in co-pendingapplication Ser. Nos. 08/282,192, filed Jul. 28, 1994, 08/159,815, filedNov. 30, 1993, and 08/173,899, filed Dec. 27, 1993, which areincorporated herein by reference. As described in those applications,after general anesthesia has been induced, cardiopulmonary bypass isinitiated by placing a venous cannula in a major peripheral vein such asa femoral vein, and placing an arterial cannula in a major peripheralartery such a femoral artery. The venous and arterial cannulae areconnected to a cardiopulmonary bypass system, which includes anoxygenator for oxygenating blood withdrawn from the patient through thevenous cannula, a filter for removing emboli from the blood, and a pumpfor returning the blood to the patient's arterial system through thearterial cannula.

[0115] With cardiopulmonary bypass established, cardioplegic arrest maybe induced. Although conventional, open-chest external aortic crossclamping and aortic cannulation through the aortic wall may be utilized,closed-chest cardioplegia techniques are preferred. As described in theforementioned copending applications, cardioplegia may be induced on aclosed-chest patient by introducing an aortic catheter into a femoralartery or other major peripheral artery, transluminally positioning thedistal end of the aortic catheter in the ascending aorta, and expandingan expandable member such as a balloon on the distal lend of the aorticcatheter to occlude the ascending aortic lumen between the coronaryostia and the brachiocephalic artery. A cardioplegic agent, preferablycomprising a potassium chloride solution mixed with blood, is thendelivered through a lumen of the aortic catheter into the ascendingaorta, where the cardioplegic fluid flows into the coronary arteries,perfusing the myocardium and arresting cardiac function. A ventingcatheter may also introduced into the right side of the heart or intothe pulmonary artery from a peripheral vein, as described in copendingapplication Ser. No. 08/415,238, filed Mar. 30, 1995, which isincorporated herein by reference. In addition, a retrograde cardioplegiacatheter may be introduced from another peripheral vein into thecoronary sinus for delivering cardioplegic fluid into the coronary sinusunder sufficient pressure to flow in a retrograde manner through thecoronary veins to perfuse the myocardium, as described in copendingapplication Ser. No. 08/372,741, filed Jan. 12, 1995, which isincorporated herein by reference.

[0116] As an alternative to these endovascular techniques, cardioplegicarrest may be induced by occluding the ascending aorta with athoracoscopic cross-clamp positioned externally on the aorta through anintercostal port in the anterior chest. Cardioplegic fluid may then bedelivered upstream of the clamp with a cannula intraluminally positionedin the aorta from a peripheral artery, or by penetrating the aortic wallwith a cannula introduced thoracoscopically. Such techniques aredescribed in copending application Ser. No. 08/173,899, filed Dec. 27,1993, which has been incorporated herein by reference.

[0117] In order to obtain access to the heart from the right lateralside of the chest, the right lung must be collapsed. This may beaccomplished by inserting an endotracheal tube into the right main stembronchus and applying a vacuum so as to deflate the lung.

[0118] With cardiac function arrested and the patient's circulationsupported by extracorporeal cardiopulmonary bypass, the patient is readyfor the valve repair or replacement procedure. Referring to FIG. 35, anumber of percutaneous cannulae, hereinafter referred to as “ports,” arepositioned in the anterior chest and right lateral chest to provideaccess into the chest cavity. In most cases. 3 to 5 ports are required,including a retraction port 332 located in the anterior chest over theright lateral wall of the right atrium, an oval port 334 located in theright lateral chest in the second, third, fourth, fifth or sixthintercostal space, and at least one instrument port 336 in the rightlateral chest or anterior chest for introduction of instruments orvisualization devices. Retraction port 332 and instrument ports 336 areconfigured for placement within an intercostal space without requiringretraction of the ribs, and are usually 5-12 mm in diameter. Tointroduce the ports, a small puncture or incision is made in theintercostal space at the desired location, and, with an obturatorpositioned in the lumen of the ports, they are advanced through thepuncture or incision.

[0119] Oval port 334, illustrated in FIG. 36A-36D, is also configuredfor placement within an intercostal space without retraction of ribs,and has a width of less than about 30 mm, and preferably less than about25 mm. Oval port 334 has a percutaneous tube 340 having a flange 342 atits proximal end to engage the outside of the chest when the oval portis introduced. A plurality of tie-down holes 343 are provided in flange342 to facilitate securing oval port 334 to the patient by means ofsutures or other tie-down means passed through holes 343. Percutaneoustube 340 has a length sufficient to extend from outside of the chest,through the intercostal space, and into the chest cavity just beyond theinterior of the chest wall, the length typically being in the range of30-50 mm. Percutaneous tube 340 has an inner lumen 338 with shape anddimensions selected to allow an annuloplasty ring or replacement valveon a holder to be introduced through it using delivery handle 10. Innerlumen 338 usually has a width of about 10-30 mm, and preferably 15-25mm, and a height of about 25-75 mm, preferably 30-50 mm. The exact widthand height will be determined by the width (or diameter) and height ofthe particular annuloplasty ring or replacement valve and holder beingused in the procedure. It is usually desirable to begin the procedurewith an oval port 334 of the minimum size necessary to assess thecondition of the native valve and to allow introduction of valve sizingdisks. For example, an oval port 334 having a width of about 15-20 mmmay be used initially. When the size of the annuloplasty ring orprosthetic valve to be used has been selected, the smaller oval port maybe replaced, if necessary, with a larger oval port to accommodate theprosthesis.

[0120] Oval port 334 may also include a suture organizing ring 344attached to flange 342 so as to surround inner lumen 338. Organizingring 344 has a plurality of circumferentially-spaced radial slots 346 inwhich a suture thread may be received and retained by friction. Slots346 have tapered upper ends 348 to allow a suture thread to be easilyguided into the slot. Suture organizing ring 344 allows sutures placedin the heart for attachment of a prosthesis to be drawn through innerlumen 338 and temporarily placed in slots 346 so as to keep the suturesindividually separated and untangled, as described more fully below.

[0121] In order to facilitate introducing oval port 334 through apuncture or small incision between the ribs, an obturator 350 may beslidably inserted into inner lumen 338, as illustrated in FIGS. 37A-B.Obturator 350 includes an oval shaft 352 positionable within inner lumen338 and a tapered or pointed distal end 354 which extends distally ofthe distal end of percutaneous tube 340. A handle 356 is attached to theproximal end of oval shaft 352 and has a distal face 358 for engagingflange 342 on oval port 334. Handle 356 has shape and dimensionssuitable for grasping in the hand of the user and applying adistally-directed force for percutaneous introduction. Once oval port334 has been introduced through an intercostal space, obturator 350 isremoved from inner lumen 338.

[0122] In addition to the oval configuration shown, oval port 334 mayhave an inner lumen of various other shapes, including race-track,rectangular, trapezoidal, elliptical or circular. Alternatively, ovalport 334 may be made of a flexible or deformable material to allow it tobe shaped by the user or to conform to the shape of the intercostalspace. In addition, other means of tissue retraction may be used inplace of oval port 334, such as a 3-sided channel-shaped member, or awound retractor having a pair of adjustable parallel blades which can beplaced in an intercostal incision and used to create a space by wideningthe distance between the blades. All of these may fall within the scopeof the invention to the extent they facilitate introduction of aprosthetic annuloplasty ring or valve through an intercostal spacewithout significant retraction or removal of the ribs or sternum.

[0123] Referring again to FIG. 35, with ports 332, 334, 336 in position,surgery within the chest cavity may begin. Much, if not all of theprocedure may be carried out under direct vision by illuminating thechest cavity with a light source or light guide positioned in aninstrument port or in the oval port and looking through the inner lumenof oval port 334 or through one of the instrument ports. Head-mountedsurgical loupes specially designed for looking through a small incisionor cannula may be utilized to facilitate direct vision through a port,such as the devices described in U.S. Pat. Nos. 4,836,188, 4,196,966,and 4,807,987, which are incorporated herein by reference. A fiberopticbundle may also be attached to or embedded in the wall of one ofinstrument ports 336 or in percutaneous tube 340 of oval port 334 totransmit light into the chest from a light source outside the chest, inthe manner disclosed in copending application Ser. No. 08/227,366, filedApr. 13, 1994, which is incorporated herein by reference. In most cases,however, it will be desirable to introduce a thoracoscope 360 through aninstrument port 336 to provide additional illumination and visualizationof the chest cavity, preferably by means of a video camera mounted tothoracoscope 360 which transmits a video image to a monitor (not shownin FIG. 35). Thoracoscope 360 may comprise a rigid thoracoscope with astraight end or an angled end such as those available from, for example,Olympus Corp., Medical Instruments Division, Lake Success, N.Y.Alternatively, a thoracoscope with an articulated end steerable by meansof an actuator at the proximal end of the device may be used, such asthe Welch Allyn DistalVu™ (formerly Baxter DistalCam™ 360), availablefrom Welch Allyn, Inc., of Skaneateles Falls, N.Y.

[0124] Thoracoscopic surgical instruments are then introduced in orderto form an opening in the pericardium, which surrounds the heart. If theright lung is not sufficiently collapsed, atraumatic retractioninstruments may be introduced through one of the ports to push the lungposteriorly such that the pericardium is visible by looking through ovalport 334 or through one of instrument ports 336. Thoracoscopic scissors362 and graspers 364 are then introduced through oval port 334 orinstrument port 336 and used to cut an opening in the pericardium P.Suitable thoracoscopic instruments for use in the method of theinvention are described in copending application Ser. Nos. 08/281,962,filed Jul. 28, 1994, and Ser. No. 08/194, 946, filed Feb. 11, 1994,which are incorporated herein by reference.

[0125] With an opening formed in the pericardium, the right lateral wallof the left atrium is in a direct line of sight from the right lateralchest looking through inner lumen 338 of oval port 334. An atriotomyincision AI is then made in the left atrial wall W by means ofthoracoscopic scissors 362 and graspers 364 introduced throughinstrument ports 336 and/or through oval port 334, as illustrated inFIG. 38. Atriotomy AI is located between and just anterior to thepulmonary veins PV.

[0126] Before making atriotomy incision AI, it may be advantageous toflood the thorax with cool carbon dioxide (CO₂) and to maintain this CO₂blanket around the heart throughout the procedure in order to helpexclude air from the chest cavity and heart, thereby reducing the riskof trapped air embolism in the heart. In such cases, retraction port332, oval port 334 and instrument ports 336 may include gaseous sealslike those used in laparoscopic trocar sleeves to prevent loss of CO₂from the chest cavity and/or introduction of air into the chest cavity.CO₂ may be introduced through an insulation tube introduced through oneof these ports, or through an insulation lumen extending through one ofthe ports.

[0127] Referring to FIGS. 39-40, an endoscopic atrial retractor 366 isthen inserted through retraction port 332, positioned in atriotomy AI,and pulled anteriorly so as to retract atriotomy AI open. A rake-typeretractor with several collapsible blades 368 (best seen in FIG. 40),coupled to the end of an elongated handle 370 may be used for thispurpose, as described in copending application Ser. No. 08/281,962,filed Jul. 28, 1994. Alternatively, a retractor having a single largertransverse blade which is attachable and removable from an elongatedhandle may be used, as described in copending application Ser. No.08/294,454, filed Aug. 23, 1994, which is incorporated herein byreference. The single blade may be introduced through inner lumen 338 ofoval port 334 while the handle is introduced through retraction port332, the blade then being attached to the handle within the chestcavity, and positioned within atriotomy AI to facilitate retraction.With atriotomy AI retracted, direct visualization of mitral valve MV ispossible through inner lumen 338 of oval port 334, as shown in FIG. 40.

[0128] Under either direct visualization through a port or video-basedviewing using thoracoscope 360, the condition of mitral valve MV is thenassessed to determine whether the valve may be repaired, or whetherreplacement of the valve is necessary. If the surgeon determines thatrepair is the more suitable option, a number of repair procedures may beperformed, including annuloplasty, wherein an annuloplasty ring isattached around the native valve to contract the annulus, quadrangularresection, in which a portion of a valve leaflet is excised and theremaining portions of the leaflet are sewn back together,commissurotomy, wherein the valve commissures are incised to separatethe valve leaflets, shortening of the chordae tendonae, reattachment ofsevered chordae tendonae or papillary muscle tissue, and decalcificationof the valve leaflets or annulus. Several of these procedures may alsobe performed on the same valve. In particular, annuloplasty rings may beused in conjunction with any repair procedures where contracting orstabilizing the valve annulus might be desirable.

[0129] In a preferred method of annuloplasty according to the invention,a prosthetic annuloplasty ring is introduced through oval port 334 andattached to an interior wall of the heart around the native valveannulus VA of mitral valve MV. In order to select an annuloplasty ringof the proper size, the native valve must be measured using a sizingdevice such as sizing disk 180 or 194 described above in connection withFIGS. 21-22. As illustrated in FIG. 39, sizing disk 180 is attached tocoupling member 26 on the distal end of delivery handle 10, and pivotedrelative to shaft 20 into an orientation appropriate for introductionthrough inner lumen 338 of oval port 334. Preferably, in thisorientation, the lower face 185 of sizing disk 180 will be generallyparallel to the longitudinal axis of shaft 20. Sizing disk 180 is thenintroduced through oval port 334 and through atriotomy AI using deliveryhandle 10, until the sizing disk is within the left atrium LA. Sizingdisk 180 is then pivoted using actuator button 30 on handle 28 such thatlower face 185 is facing mitral valve MV, approximately perpendicular tothe longitudinal axis of shaft 20. Under visualization with thoracoscope360 and/or direct vision through a port, sizing disk 180 is positionedadjacent or against mitral valve MV and the size of the native valve ismeasured, usually by measuring the width of the anterior leaflet AL(FIG. 40) by comparing the width of sizing disk 180, and by measuringthe spacing between the native valve commissures or trigones usingnotches 184 or other markings on sizing disk 180. Sizing disks ofvarious sizes may be interchanged on delivery handle 10 and positionedadjacent mitral valve MV until the proper size has been determined.

[0130] With an annuloplasty ring of the appropriate size identified,sutures are placed in or just outside of the native valve annulus VA, asillustrated in FIG. 40. Double-armed sutures 372 of braided polyester orNylon and having a length of about 30-36 cm are preferred. Thoracoscopicneedle drivers 374 may be used to grasp a curved suture needle 376 onone end of a suture 372, position the suture in left atrium LA throughoval port 334 or an instrument port 336, and drive needle 374 throughvalve annulus VA in the manner shown in FIG. 40. Appropriatethoracoscopic needle drivers are described in copending application Ser.Nos. 08/281,962, filed Jul. 28, 1994, and Ser. No. 08/194, 946, filedFeb. 11, 1994, which have been incorporated herein by reference. Sutureplacement is visualized either by direct vision through oval port 334 orby using thoracoscope 360. Usually between 8 and 20 double-armed sutures372 are placed in valve annulus VA. After being placed, suture needles376 are drawn out of the chest cavity through inner lumen 338 of ovalport 334, and sutures 372 are inserted into slots 346 in organizing ring344.

[0131] Sutures 372 are next placed through annuloplasty ring 90 onholder 70, as illustrated in FIG. 41. Holder 70 is attached to holdercoupling 26 on delivery handle 10, which optionally may beheld in aclamping fixture 380 attached to the operating table 382. Each sutureneedle 376 is grasped in a needle driver 374 and passed throughannuloplasty ring 90. Sutures 372 may then be placed in a sutureorganizer, or a pair of hemostats (not shown) may be clamped onto eachneedle 376 and suspended from annuloplasty ring 90 to maintain tensionon the sutures and prevent tangling.

[0132] Annuloplasty ring 90 is then introduced through inner lumen 338of oval port 334, as illustrated in FIG. 42. Holder 70 is pivotedrelative to shaft 20 so that annuloplasty ring 90 will pass throughinner lumen 338 without interference, preferably in an orientation inwhich a plane containing the lower surface of annuloplasty ring 90 isparallel to the longitudinal axis of shaft 20. As annuloplasty ring 90is advanced into the left atrium LA, tension is maintained on sutures372 by organizer ring 344 or by individual hemostats (not pictured)clamped onto each pair of needles 376 on sutures 372 so that theannuloplasty ring slides along the sutures up to the mitral valve MV.Once through oval port 334 and into the chest cavity, actuator button 30on delivery handle 10 may be actuated so that annuloplasty ring 90pivots into an orientation suitable for attachment within the leftatrium LA, preferably in an orientation in which the lower surface ofthe annuloplasty ring is parallel to the mitral valve and perpendicularto the longitudinal axis of shaft 20. Annuloplasty ring 90 is positionedin contact with the interior wall of the left atrium in which sutures372 have been placed so as to surround the native valve annulus VA.

[0133] Holder 70 may then be removed from annuloplasty ring 90 bycutting any sutures used to retain ring 90 on the holder, and urgingring 90 out of channel 76 on the side of holder 70. Holder 70 anddelivery handle 10 may then be removed from the chest cavity.

[0134] Needles 376 are then trimmed from each suture 372, and, asillustrated in FIGS. 43-44, knots 384 are tied in each suture 372 andpushed into left atrium LA and against annuloplasty ring 90 by anendoscopic knot pusher 386. Knot pusher 386 preferably comprises a knotpusher with a rounded distal end 388 and a single lateral eyelet 390, asdisclosed in copending application Ser. No. 08/288,674, filed Aug. 10,1994, which is incorporated herein by reference. This knot pusher isparticularly well-adapted for the method of the invention due its longlength and low profile, and due to the quickness with which knots can betied and the ease with which they can be slid into the left atrium fromoutside of the chest cavity. After each suture 372 is tied securelyagainst annuloplasty ring 90, the suture ends are trimmed off usingthoracoscopic scissors 362.

[0135] If neither annuloplasty nor any other repair procedure willadequately treat the diseased valve, the surgeon may elect to replacethe native valve with a replacement valve. The techniques forintroducing and securing a replacement valve within the heart will beanalogous to those described above for annuloplasty ring 90, and arefurther described in copending application Ser. No. 08/281,962, filedJul. 28, 1994, which has been incorporated herein by reference. Thenative valve may be sized for replacement using valve sizing disks 220or 238, shown in FIGS. 23-25, which are introduced into left atrium LAusing delivery handle 10 by techniques similar to those described abovefor sizing mitral valve MV for an annuloplasty ring. Once a prostheticvalve 262 of the appropriate size is identified, thoracoscopic needledrivers 274 may be used to place sutures around the native valveannulus, in much the same way as described above for annuloplasty ring90, using a mattress stitch or everted mattress stitch. As in the caseof annuloplasty, the sutures are withdrawn from the body cavity throughinner lumen 338 of oval port 334 and placed in slots 346 of organizingring 344. Each suture is then placed through sewing ring 266 ofprosthetic valve 262 outside of the chest cavity. Optionally, prior tosuture placement, the valve leaflets of the native valve may be removedusing thoracoscopic scissors 362.

[0136] Prosthetic valve 262, held on valve holder 260 (described abovein connection with FIGS. 26-34), is then attached to delivery handle 10to facilitate delivery of the replacement valve through oval port 334into left atrium LA. During introduction, prosthetic valve 262 ispivoted into an orientation in which it will pass through inner lumen338 of oval port 334 without interference, preferably with thelongitudinal axis of sewing ring 266 approximately perpendicular to thelongitudinal axis of shaft 20 as shown in FIG. 30A. Once within thechest cavity, prosthetic valve 262 is pivoted into an orientationsuitable for attachment at the native valve position in the heart,preferably with the longitudinal axis of sewing ring 266 perpendicularto the interior wall of the heart to which the valve will be attached,and parallel to the longitudinal axis of shaft ,20 as shown in FIG. 30B.Prosthetic valve 262 may then be removed from holder 260 by cuttingretaining suture 300, and holder 260 and delivery handle 10 are removedfrom the chest cavity.

[0137] It may be necessary to seat the prosthetic valve firmly againstthe native valve annulus after holder 260 and delivery handle 10 havebeen removed. A valve seater 400, illustrated in FIG. 45A, may beutilized for this purpose. Valve seater 400 comprises an elongated rigidshaft 402, and a valve engaging tip 404 at its distal end. Valveengaging tip 404 has a concave end 406 radiused so as to match sewingring 266, and is made of a soft polymer such as silicone rubber orthermoplastic elastomer (TPE) with a durometer in a range of 20 to 70Shore A so that it can contact the prosthetic valve without damaging it.Valve seater 400 has a length of at least about 20 cm and usually atleast 30 cm so as to reach the mitral position from outside the chestcavity via an intercostal port, and a diameter of less than about 25 mm,usually less than about 8 mm, so as to be positionable through anintercostal port. In this way, valve seater 400 may be positionedthrough an intercostal port (e.g. oval port 334) and tip 404 can be usedto push against sewing ring 266 to seat the prosthetic valve against thenative valve annulus.

[0138] Knots are then formed in the sutures and pushed into the leftatrium using thoracoscopic knot pusher 386. The sutures are then trimmedoff above the knot using thoracoscopic scissors 362, as described above.

[0139] Before or after the prosthetic valve has been secured in theheart, it may be necessary to test its leaflets to ensure they arefunctioning properly. A leaflet testing device as illustrated in FIG.45B may be used for this purpose. Leaflet testing device 408 comprises arigid shaft 410 and a leaflet-engaging tip 412 attached to the distalend of shaft 410. Shaft 410 has a length of at least about 20 cm usuallyat least 30 cm, and a diameter of less than about 25 mm, usually lessthan about 8 mm, to reach the mitral position from outside the chest viaa right lateral intercostal port. Tip 412 has a tapered distal end 414configured to push lightly on each valve leaflet 270 (FIG. 28) to fullyopen the leaflet without interference with annular frame 264. Becausevalve leaflets 270 may be fragile and susceptible to damage, tip 412 ismade of a soft polymer such as silicone rubber or thermoplasticelastomer (TPE) with a durometer in a range of 20 to 70 Shore A. In thisway, leaflet testing device 408 may be introduced through oval port 334and each leaflet of the valve prosthesis pushed gently distally toensure the leaflets are opening properly.

[0140] For certain types of heart valves prostheses, it may also bedesirable to rotate the annular frame and valve leaflets relative to thesewing ring after the prosthesis has been secured in the heart. For thispurpose, a specially designed valve rotator may be used. The valverotator has an atraumatic rotator head for engaging the valve frameand/or leaflets similar to that disclosed in U.S. Pat. No. 5,403,305,which is incorporated herein by reference. However, rather than a socketwhich connects the head to a handle such that the face of the head isperpendicular to the handle, the rotator head used in the method of thepresent invention has a handle coupling like handle coupling 80 of FIGS.5A-5C. In this way the rotator head may be connected to holder coupling26 of delivery handle 10 so that it may be positioned in an edge-firstorientation for introduction through an intercostal port, then pivotedinto a face-first orientation for rotating the valve prosthesis.

[0141] When annuloplasty ring 90 or replacement valve 262 has beensecured within the heart, atriotomy AI may be closed, as illustrated inFIG. 46. Thoracoscopic needle drivers 374 may be used to grasp a curvedneedle 392 on a suture 394, introduce suture 394 into the chest cavitythrough oval port 334 or an instrument port 336, and drive needle 392through the left atrial wall to create a series of stitches acrossatriotomy AI. Alternatively, an endoscopic stapling device such as anAutoSuture™ Powered Multifire Endo TA60, available from United StatesSurgical Corp. of Norwalk, Conn., or an endoscopic fascia stapler, maybe inserted through an anterior instrument port 336 and positionedaround atriotomy AI to drive a series of staples into the atrial wall toclose the atriotomy.

[0142] The opening formed in the pericardium may be closed with suturesor staples in a manner similar to that used for closing atriotomy AI.However, in most cases, closure of the pericardium is not necessary, andthe opening may be left in it without adverse effect.

[0143] To complete the operation, cardiac function is restored bydiscontinuing delivery of cardioplegic fluid, terminating occlusion ofthe ascending aortic lumen, and perfusing the myocardium with warmblood. Preferably, where an aortic catheter has been used for aorticocclusion and cardioplegic fluid delivery, the expandable member on thedistal end of the aortic catheter is deflated and warm blood is allowedto flow into the coronary arteries. If sinus rhythm is does not returnimmediately, electrical defibrillation may be used to stimulate theheart and/or pacing leads may be placed through a port into the heartmuscle to pace the heart for a period of time post-operatively. Once theheart is beating normally, the aortic catheter may be removed from thepatient, along with any venting catheter or retrograde cardioplegiadelivery catheter which, may have been used. Chest tubes may be insertedinto the chest to provide drainage. The patient is then weaned fromcardiopulmonary bypass, and the arterial and venous cannulae are removedfrom the patient. All venous and arterial punctures or cut-downs areclosed. Any endotracheal tubes used for ventilation are removed.Retraction port 332, oval port 334, and instrument ports 336 are removedfrom the chest, and all intercostal incisions and punctures are closed.The patient is then recovered from anesthesia.

[0144] It will be understood to those of ordinary skill in the art that,while the invention has been described specifically in the context ofmitral valve repair and replacement, the devices and methods disclosedherein will have equal application to a number of other cardiac valves,including the aortic valve, the tricuspid valve, and the pulmonaryvalve. While the specific locations of these valves and the surgicalapproaches utilized to access these valves may differ from thosedescribed in detail above, the devices and methods described herein areeasily adapted for use on valves other than the mitral without departingfrom the scope of the invention. For example, the tricuspid or pulmonaryvalves may be accessed similarly to the mitral valve through anintercostal port in the right lateral chest to access the right atrium(for the tricuspid valve) or the right ventricle (for the pulmonaryvalve), on the other hand, the aortic valve can be accessed from anintercostal port in the upper anterior chest via an incision in theascending aorta. Moreover, although the devices and methods of theinvention have been described in connection with specific types ofprosthetic annuloplasty rings and replacement valves, these are given byway of example only. It should be understood that a wide variety ofprostheses may be implanted using the devices and methods of theinvention with little if any modification to the specific embodimentsdescribed above.

[0145] Using the devices and methods of the invention, a cardiac valvemay be repaired or replaced using minimally-invasive techniques whicheliminate the need for a median sternotomy or other gross thoracotomyinvolving cutting, removal, or substantial retraction of the ribs orsternum. As a result, patient recovery is accelerated, pain and traumaare greatly reduced, and the morbidity and mortality of valve repair andreplacement procedures may be decreased. Not only may this result inbetter outcomes and reduced costs for the thousands of patients whoundergo cardiac valve surgery each year, but may allow thousands moresuffering from valve disease to receive surgical treatment who wouldotherwise be unable or unwilling to tolerate the pain and trauma ofopen-heart valve surgery.

[0146] While the above is a complete description of the preferredembodiments of the invention, various alternatives, modifications,additions, and substitutions are possible without departing from thescope thereof. Therefore, the above should not be taken as limiting thescope of the invention, which is defined by the following claims.

What is claimed is:
 1. A system for repairing a heart valve in apatient's heart, the heart being disposed within a chest cavity definedby a plurality of ribs, each rib being separated from an adjacent rib byan intercostal space having an intercostal width when the ribs are in anunretracted position, the system comprising: an annuloplasty deviceadapted for attachment within the heart around the heart valve; a deviceholder for releasably holding the annuloplasty device; and an elongatedhandle for delivering the device holder and annuloplasty device througha percutaneous penetration in the intercostal space, the handle beingattached to the device holder such that the handle, the device holder,and the annuloplasty device together have a profile with a profileheight smaller than the intercostal width.
 2. The system of claim 1further comprising a retraction means for retracting tissue in thepercutaneous penetration to facilitate positioning the annuloplastydevice therethrough while leaving the ribs in the unretracted position.3. The system of claim 2 wherein the retraction means comprises acannula having a distal end positionable in the chest cavity through theintercostal space, a proximal end, and an inner lumen through which theannuloplasty device and device holder may be positioned while attachedto the handle.
 4. The system of claim 3 wherein the inner lumen of thecannula has a cross-sectional height and a cross-sectional width, thecross-sectional height being larger than the cross-sectional width. 5.The system of claim 4 wherein the annuloplasty device has a device widthin a direction perpendicular to the profile height, the cross-sectionalheight of the inner lumen being larger than the device width, and thecross-sectional width of the inner lumen being larger than the profileheight.
 6. The system of claim 5 wherein the cross-sectional height isat least about 1.5 times the cross-sectional width.
 7. The system ofclaim 4 wherein the inner lumen has a shape selected from oval,racetrack, rectangular, and trapezoidal.
 8. The system of claim 3further comprising an obturator removably positionable in the innerlumen to facilitate introduction of the cannula through the percutaneouspenetration.
 9. The system of claim 2 further comprising a sutureorganizing means for retaining a plurality of sutures in preselectedpositions outside the chest cavity.
 10. The system of claim 9 whereinthe suture organizing means is attached to the retraction means.
 11. Thesystem of claim 10 wherein the retraction means comprises a cannulahaving a distal end positionable in the chest cavity through theintercostal space, a proximal end, and an inner lumen, and the sutureorganizing means comprises a plurality of slots disposed in a proximalend of the cannula around the inner lumen.
 12. The system of claim 1wherein the handle has a length of at least about 20 cm.
 13. The systemof claim 1 wherein the profile height is less than about 25 mm.
 14. Thesystem of claim 1 wherein a bottom side of the annuloplasty device isconfigured to be positioned in contact with an internal wall of theheart around the heart valve. the bottom side defining a first plane,and wherein the device holder is configured to attach to the handle suchthat a longitudinal axis of the handle is at an angle of about 0°+/−45°relative to the first plane.
 15. The system of claim 14 wherein thedevice holder is pivotably coupled to the handle so as to be pivotableabout an axis perpendicular to the longitudinal axis of the handlebetween a first orientation in which the annuloplasty device may bepositioned through the intercostal space and a second orientation inwhich the annuloplasty device may be secured in the heart around theheart valve.
 16. The system of claim 15 wherein, in the firstorientation, the first plane is at an angle of 0°+/−45° relative to thelongitudinal axis, and in the second orientations the first plane is atan angle of 90°+/−20° relative to the longitudinal axis.
 17. The systemof claim 15 wherein the handle further comprises an actuator at aproximal end thereof for pivoting the device holder between the firstand second orientations.
 18. The system of claim 1 wherein the deviceholder includes retention means for retaining the annuloplasty device onthe device holder.
 19. A method of repairing a heart valve in apatient's heart, the heart being disposed within a chest cavity definedby a plurality of ribs attached to a sternum, each rib being separatedfrom an adjacent rib by an intercostal space having an intercostal widthwhen the ribs are in an unretracted position, the method comprising:establishing cardiopulmonary bypass; arresting the patient's heart;forming a percutaneous penetration into the chest cavity through anintercostal space; forming a cardiac penetration into the heart throughan outer wall of the heart; positioning an annuloplasty device throughthe percutaneous penetration and the cardiac penetration into the heart;and securing the annuloplasty device to an internal wall of the heartaround the heart valve; wherein each of the above steps are performedwith the ribs and sternum intact and substantially unretracted.
 20. Anadaptor to facilitate delivering an annuloplasty device into a patient'sheart for repairing a heart valve therein, the annuloplasty device beingmounted on a holder having a fitting for connection to a handle, and theheart being disposed within a chest cavity defined by a plurality ofribs, each rib being separated from an adjacent rib by an intercostalspace having an intercostal width when the ribs are in an unretractedposition, the adaptor comprising: a body having a distal end and aproximal end; a proximal connector on the proximal end adapted forconnection to a delivery handle; and a distal connector on the distalend adapted for connection to the fitting on the holder; wherein theproximal connector is adapted to connect to the delivery handle along afirst axis, and the distal connector is adapted to connect to thefitting along a second axis, the first axis being at an angle of90°+/−45° relative to the second axis.